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OpenTrials
Completed

NCT Number: NCT04398784

Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population

This pilot study aims to measure the effects of an intervention of 22.5 grams of freeze-dried whole blueberry powder in water drunk daily. Measures are on outcomes of depression, biological markers of inflammation and oxidative stress, and microbial populations in the intestines.

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Key information

Conditions

Depression Anxiety Disorders Behavior Behavioral Symptoms Depression, Anxiety Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cottonport Family Clinic, Cottonport, Louisiana, United States

Loading trial locations.

About this study

A 29 week double-blind, placebo-controlled, crossover intervention assessing the effect of a blueberries on behavioral symptoms related to depression, biological markers of inflammation and oxidative stress, and gut microbiome measures. A total of 45 participants will be randomly assigned to either a blueberry-first or placebo-first group; participants will take 22.5 grams of either freeze-dried blueberry powder or matched placebo powder mixed with water daily for 12 weeks. This period is followed by a 4 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with a stable diagnosis of Major Depressive Disorder (>1 year prior to enrollment)
  • Males and females 18-70 years of age
  • Subjects with sleep disruptions
  • Subjects currently prescribed to a non-antipsychotic mono-pharmacotherapies
  • English speaking subjects only (all evaluations are in English)

Subjects with the following inflammatory disorders that exhibit low to moderate symptoms:

  • Hypertension (mild=140/80-160/90; moderate= 160/90-180/100)
  • Asthma (requiring 2 or fewer inhalations of rescue inhaler per day)
  • Gastroesophageal reflux disease
  • Irritable bowel syndrome (controlled, <3 bowel movements a day)
  • Arthritis (controlled)
  • Chronic stomach ulcers (controlled)
  • Obesity BMI <40
  • Chronic pain
  • Fibromyalgia
  • Chronic Fatigue Syndrome
  • Type I or Type II diabetes (controlled)
  • Subjects that are compliant with current treatment regimens and clinic appointments
  • Subjects taking intermittent or infrequent doses of acetaminophen or NSAIDs
  • Subjects who currently smoke or have a history of smoking

Exclusion criteria

Subjects with current diagnosis or history of the following conditions; or subjects currently on medication for any of the following conditions:

  • Severe Cardiovascular disease; Heart attack/pacemaker
  • Cancer
  • Autoimmunity Disorders
  • Crohn's Disease or Ulcerative Colitis
  • Alzheimer's Disease
  • Parkinson's Disease
  • Multiple Sclerosis
  • Uncontrolled Diabetes: Type I or II
  • Severe irritable bowel disease (>3 stools per day)
  • Hypertension (severe >180/100)
  • Hypotension (<100/60)
  • Epilepsy
  • Autism Spectrum Disorder
  • Schizophrenia
  • Psychosis/Psychotic Symptoms
  • Uncontrolled Hypo/Hyperthyroidism
  • Women who are pregnant, nursing, lactating, or planning to become pregnant within timeline of study
  • Subjects who are blind or deaf
  • Subjects who are allergic to blueberries or other similar foods or drinks (e.g. wine), or subjects who are allergic to red or blue food dye agents
  • Subjects who do not like the taste of blueberries
  • Subjects who do not want to disclose information related to their Major Depressive Disorder
  • Subjects who do not want to be subjected to blood draws
  • Subjects who consume >4 cups of blueberries per week or other foods/drinks with significant polyphenol content
  • Subjects supplementing with elderberry syrup >4 times per week
  • Subjects who have a planned surgery during the timeline of the study
  • Subjects prescribed to antipsychotics
  • Subjects using acetaminophen or NSAIDS (drugs targeting pro-inflammatory paths) chronically or exceeding recommended daily doses
  • Subjects chronically on Decadron, Dexamethasone, or Prednisone; or other oral steroids
  • Subjects on any augmenting agents (the following is not an inclusive list):

Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Clozaril(clozapine), Symbyax (olanzapine/fluoxetine), Geodon (ziprasidone)

  • Subjects supplementing with devil's claw, fenugreek, guar gum, Panax ginseng, and Siberian ginseng
  • Subjects who have a history of suicidal ideation or suicide attempt
  • Subjects with a history or record of physical violence toward self or others
  • Subjects who will jeopardize their job if they miss work for appointments
  • Subjects with a history of addiction, except cigarettes

Treatment and study plan

Freeze Dried Blueberry Powder - 71717

Dietary Supplement

Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption.

Other names: Tifblue/Rubel 50/50 Blend

USHBC Blueberry Placebo Formula #114

Dietary Supplement

Blueberry flavor- and color-matched placebo powder.

Primary outcomes

  1. Major Depression Inventory (MDI)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.

  2. Major Depression Inventory (MDI)

    Time frame: Day 30 of treatment intervention

    A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.

  3. Major Depression Inventory (MDI)

    Time frame: Day 60 of treatment intervention

    A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.

  4. Major Depression Inventory (MDI)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.

  5. Major Depression Inventory (MDI)

    Time frame: Day 30 of placebo intervention

    A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.

  6. Major Depression Inventory (MDI)

    Time frame: Day 60 of placebo intervention

    A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time, and 5=all the time; the higher the score, the more severe the depressive symptom.

  7. Generalized Anxiety Disorder 7-item (GAD-7) scale

    Time frame: Day 1 of treatment intervention, before treatment consumption

    A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.

  8. Generalized Anxiety Disorder 7-item (GAD-7) scale

    Time frame: Day 30 of treatment intervention

    A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.

  9. Generalized Anxiety Disorder 7-item (GAD-7) scale

    Time frame: Day 60 of treatment intervention

    A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.

  10. Generalized Anxiety Disorder 7-item (GAD-7) scale

    Time frame: Day 1 of placebo intervention, before placebo consumption

    A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.

  11. Generalized Anxiety Disorder 7-item (GAD-7) scale

    Time frame: Day 30 of placebo intervention

    A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.

  12. Generalized Anxiety Disorder 7-item (GAD-7) scale

    Time frame: Day 60 of placebo intervention

    A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.

  13. Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.

  14. Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

    Time frame: Day 60 of treatment intervention

    A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.

  15. Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.

  16. Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

    Time frame: Day 60 of placebo intervention

    A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.

Secondary outcomes

  1. C-Reactive Protein (CRP) Measure

    Time frame: Immediately after enrollment, 30 days before start of intervention

    Biological measure of C-Reactive Protein from participant blood sample

  2. CRP Measure

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Biological measure of C-Reactive Protein from participant blood sample

  3. CRP Measure

    Time frame: Day 30 of treatment intervention

    Biological measure of C-Reactive Protein from participant blood sample

  4. CRP Measure

    Time frame: Day 60 of treatment intervention

    Biological measure of C-Reactive Protein from participant blood sample

  5. CRP Measure

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Biological measure of C-Reactive Protein from participant blood sample

  6. CRP Measure

    Time frame: Day 30 of placebo intervention

    Biological measure of C-Reactive Protein from participant blood sample

  7. CRP Measure

    Time frame: Day 60 of placebo intervention

    Biological measure of C-Reactive Protein from participant blood sample

  8. Gut Microbiome Analysis

    Time frame: Day 1 of treatment intervention, before treatment consumption

    uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome

  9. Gut Microbiome Analysis

    Time frame: Day 30 of treatment intervention

    uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome

  10. Gut Microbiome Analysis

    Time frame: Day 60 of treatment intervention

    uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome

  11. Gut Microbiome Analysis

    Time frame: Day 1 of placebo intervention, before placebo consumption

    uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome

  12. Gut Microbiome Analysis

    Time frame: Day 30 of placebo intervention

    uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome

  13. Gut Microbiome Analysis

    Time frame: Day 60 of placebo intervention

    uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome

  14. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.

  15. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Day 30 of treatment intervention

    A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.

  16. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Day 60 of treatment intervention

    A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.

  17. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.

  18. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Day 30 of placebo intervention

    A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.

  19. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Day 60 of placebo intervention

    A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.

  20. Concentration of reactive oxygen species (ROS)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Electron paramagnetic resonance (EPR) to measures reactive oxygen species (ROS) in participant blood samples

  21. Concentration of reactive oxygen species (ROS)

    Time frame: Day 30 of treatment intervention

    Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples

  22. Concentration of reactive oxygen species (ROS)

    Time frame: Day 60 of treatment intervention

    Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples

  23. Concentration of reactive oxygen species (ROS)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples

  24. Concentration of reactive oxygen species (ROS)

    Time frame: Day 30 of placebo intervention

    Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples

  25. Concentration of reactive oxygen species (ROS)

    Time frame: Day 60 of placebo intervention

    Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples

  26. Concentration of quinolinic acid

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples

  27. Concentration of quinolinic acid

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples

  28. Concentration of quinolinic acid

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples

  29. Concentration of quinolinic acid

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples

  30. Concentration of quinolinic acid

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples

  31. Concentration of quinolinic acid

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples

  32. Concentration of kynurenic acid

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples

  33. Concentration of kynurenic acid

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples

  34. Concentration of kynurenic acid

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples

  35. Concentration of kynurenic acid

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples

  36. Concentration of kynurenic acid

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples

  37. Concentration of kynurenic acid

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples

  38. Concentration of kynurenine

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples

  39. Concentration of kynurenine

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples

  40. Concentration of kynurenine

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples

  41. Concentration of kynurenine

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples

  42. Concentration of kynurenine

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples

  43. Concentration of kynurenine

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples

  44. Concentration of tryptophan

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples

  45. Concentration of tryptophan

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples

  46. Concentration of tryptophan

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples

  47. Concentration of tryptophan

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples

  48. Concentration of tryptophan

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples

  49. Concentration of tryptophan

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples

  50. Concentration of indoleamine 2,3-dioxygenase (IDO)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples

  51. Concentration of indoleamine 2,3-dioxygenase (IDO)

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples

  52. Concentration of indoleamine 2,3-dioxygenase (IDO)

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples

  53. Concentration of indoleamine 2,3-dioxygenase (IDO)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples

  54. Concentration of indoleamine 2,3-dioxygenase (IDO)

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples

  55. Concentration of indoleamine 2,3-dioxygenase (IDO)

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples

  56. Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples

  57. Concentration of suicide-associated protein SKA-2

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples

  58. Concentration of suicide-associated protein SKA-2

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples

  59. Concentration of suicide-associated protein SKA-2

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples

  60. Concentration of suicide-associated protein SKA-2

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples

  61. Concentration of suicide-associated protein SKA-2

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples

  62. Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples

  63. Concentration of suicide-associated protein SAT-1

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples

  64. Concentration of suicide-associated protein SAT-1

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples

  65. Concentration of suicide-associated protein SAT-1

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples

  66. Concentration of suicide-associated protein SAT-1

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples

  67. Concentration of suicide-associated protein SAT-1

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples

  68. Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples

  69. Concentration of suicide-associated protein SLC4A4

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples

  70. Concentration of suicide-associated protein SLC4A4

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples

  71. Concentration of suicide-associated protein SLC4A4

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples

  72. Concentration of suicide-associated protein SLC4A4

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples

  73. Concentration of suicide-associated protein SLC4A4

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples

  74. Concentration of brain-derived neurotropic factor (BDNF)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples

  75. Concentration of brain-derived neurotropic factor (BDNF)

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples

  76. Concentration of brain-derived neurotropic factor (BDNF)

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples

  77. Concentration of brain-derived neurotropic factor (BDNF)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples

  78. Concentration of brain-derived neurotropic factor (BDNF)

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples

  79. Concentration of brain-derived neurotropic factor (BDNF)

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples

  80. Concentration of glial cell line-derived neurotropic factor (GDNF)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples

  81. Concentration of glial cell line-derived neurotropic factor (GDNF)

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples

  82. Concentration of glial cell line-derived neurotropic factor (GDNF)

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples

  83. Concentration of glial cell line-derived neurotropic factor (GDNF)

    Time frame: Day 1 of placebo intervention, before placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples

  84. Concentration of glial cell line-derived neurotropic factor (GDNF)

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples

  85. Concentration of glial cell line-derived neurotropic factor (GDNF)

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples

  86. Concentration of serotonin related compound serotonin transporter (SERT)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples

  87. Concentration of serotonin related compound SERT

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples

  88. Concentration of serotonin related compound SERT

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples

  89. Concentration of serotonin related compound SERT

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples

  90. Concentration of serotonin related compound SERT

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples

  91. Concentration of serotonin related compound SERT

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples

  92. Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples

  93. Concentration of serotonin related compound 5-HIAA

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples

  94. Concentration of serotonin related compound 5-HIAA

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples

  95. Concentration of serotonin related compound 5-HIAA

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples

  96. Concentration of serotonin related compound 5-HIAA

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples

  97. Concentration of serotonin related compound 5-HIAA

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples

  98. Concentration of glutamate

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples

  99. Concentration of glutamate

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples

  100. Concentration of glutamate

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples

  101. Concentration of glutamate

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples

  102. Concentration of glutamate

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples

  103. Concentration of glutamate

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples

  104. Concentration of glutamine

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples

  105. Concentration of glutamine

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples

  106. Concentration of glutamine

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples

  107. Concentration of glutamine

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples

  108. Concentration of glutamine

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples

  109. Concentration of glutamine

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples

  110. Concentration of cortisol

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples

  111. Concentration of cortisol

    Time frame: Day 30 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples

  112. Concentration of cortisol

    Time frame: Day 60 of treatment intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples

  113. Concentration of cortisol

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples

  114. Concentration of cortisol

    Time frame: Day 30 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples

  115. Concentration of cortisol

    Time frame: Day 60 of placebo intervention

    Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples

  116. Concentration of inflammation biomarker interleukin 6 (IL-6)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Luminex assay to measure interleukin 6 (IL-6) in participant blood samples

  117. Concentration of inflammation biomarker interleukin 6 (IL-6)

    Time frame: Day 30 of treatment intervention

    Luminex assay to measure interleukin 6 (IL-6) in participant blood samples

  118. Concentration of inflammation biomarker interleukin 6 (IL-6)

    Time frame: Day 60 of treatment intervention

    Luminex assay to measure interleukin 6 (IL-6) in participant blood samples

  119. Concentration of inflammation biomarker interleukin 6 (IL-6)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Luminex assay to measure interleukin 6 (IL-6) in participant blood samples

  120. Concentration of inflammation biomarker interleukin 6 (IL-6)

    Time frame: Day 30 of placebo intervention

    Luminex assay to measure interleukin 6 (IL-6) in participant blood samples

  121. Concentration of inflammation biomarker interleukin 6 (IL-6)

    Time frame: Day 60 of placebo intervention

    Luminex assay to measure interleukin 6 (IL-6) in participant blood samples

  122. Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples

  123. Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)

    Time frame: Day 30 of treatment intervention

    Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples

  124. Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)

    Time frame: Day 60 of treatment intervention

    Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples

  125. Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples

  126. Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)

    Time frame: Day 30 of placebo intervention

    Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples

  127. Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)

    Time frame: Day 60 of placebo intervention

    Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples

  128. Concentration of inflammation biomarker interferon gamma (IFN-gamma)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples

  129. Concentration of inflammation biomarker interferon gamma (IFN-gamma)

    Time frame: Day 30 of treatment intervention

    Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples

  130. Concentration of inflammation biomarker interferon gamma (IFN-gamma)

    Time frame: Day 60 of treatment intervention

    Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples

  131. Concentration of inflammation biomarker interferon gamma (IFN-gamma)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples

  132. Concentration of inflammation biomarker interferon gamma (IFN-gamma)

    Time frame: Day 30 of placebo intervention

    Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples

  133. Concentration of inflammation biomarker interferon gamma (IFN-gamma)

    Time frame: Day 60 of placebo intervention

    Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples

  134. Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)

    Time frame: Day 1 of treatment intervention, before treatment consumption

    Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

  135. Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)

    Time frame: Day 30 of treatment intervention

    Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

  136. Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)

    Time frame: Day 60 of treatment intervention

    Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

  137. Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)

    Time frame: Day 1 of placebo intervention, before placebo consumption

    Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

  138. Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)

    Time frame: Day 30 of placebo intervention

    Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

  139. Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)

    Time frame: Day 60 of placebo intervention

    Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples

Sponsors and collaborators

Lead sponsor

Louisiana State University, Baton Rouge

Other

Collaborators

  • Collective Healthcare Solutions, LLC
  • Louisiana Health Care Practitioners, LLC
  • U.S. Highbush Blueberry Council
  • uBiome, Inc.

Registry information

Official study title

Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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