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Completed

NCT Number: NCT05937165

ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

About this study

Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 5 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women aged 65 years and older
  • Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)

Exclusion criteria

*:

  • Unwilling to follow the study protocol
  • Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19)
  • Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders
  • Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease
  • Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions
  • Self-reporting history of type 1 or type 2 diabetes
  • Self-reporting any history of substance or alcohol use disorder
  • Allergy to blueberries
  • Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs
  • Are excessive tea or coffee consumers (e.g., >3 cups/day)
  • Recent and consistent use of antibiotics
  • Currently taking or advised during the intervention to take anti-depressants
  • Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener
  • All deviations must be approved by the study sponsor

Treatment and study plan

Freeze-dried Blueberry Powder

Other

Three day consumption of two doses of freeze-dried blueberry powder

Primary outcomes

  1. Urinary Flavonoid Biomarkers

    Time frame: Baseline and Day 3 of intervention

    Change in total flavonoid metabolites found in the urine. The values for the metabolites represent the relative abundance of each metabolite, rather than absolute quantification, with higher values reflecting higher levels of total flavonoid metabolites in the urine.

  2. Inflammatory Biomarker C-reactive Protein

    Time frame: Baseline and Day 3 of intervention

    Change in serum C-reactive Protein

Secondary outcomes

  1. Inflammatory Biomarker Tumor Necrosis Factor Alpha

    Time frame: Baseline and Day 3 of intervention

    Change in tumor necrosis factor alpha

  2. Inflammatory Biomarker Interleukin 6

    Time frame: Baseline and Day 3 of intervention

    Change in interleukin 6

  3. Inflammatory Biomarker Interferon Gamma

    Time frame: Baseline and Day 3 of intervention

    Change in serum interferon gamma

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study title

Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms: A Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2023
Registry last updated
Dec 15, 2025

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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