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OpenTrials
Completed

NCT Number: NCT06931977

Natural Product System and Lifestyle Modification

The goal of this clinical trial is to learn whether four dietary supplements and lifestyle changes can affect gene expression and blood markers in healthy volunteers. The main questions it aims to answer are:

1. How does daily ingestion of dietary supplements affect gene expression and hsCRP and vitamin D levels measured in blood? 2. How does daily ingestion of dietary supplements affect anthropometric measurements, sleep and physical activity, and gut microbiome composition? 3. How does daily ingestion of dietary supplements affect cognitive and subjective health parameters? 4. Do prescriptive lifestyle modifications affect the supplements' efficacy? 5. Is there a difference in outcomes between participants who take all four study supplements and those who take three study supplements with a placebo? 6. Is ingesting dietary supplements for 12 weeks safe, as measured by laboratory tests and adverse events?

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Key information

Conditions

Healthy

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

doTERRA International

Pleasant Grove, Utah, 84062, United States

About this study

This double-blind, repeated measures study will recruit healthy adults to determine efficacy, safety, anthropometric, microbiome, and epigenetic effects of consuming four dietary supplements daily for 12 weeks. Prescriptive lifestyle modifications (diet, exercise, and sleep) will be evaluated with the supplement use.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults ages 30-55 years old
  • Willing to attend three study visits at Prime Meridian Health Clinic in Pleasant Grove, Utah
  • Willing and able to undergo three blood draws over 12 weeks
  • Willing to provide urine and stool samples three times over 12 weeks
  • Willing to wash out of all internally consumed essential oils or botanical products for at least 2 weeks prior to starting the study, and willing to maintain the washout for the duration of the study (14 weeks).
  • Willing to wash out of all fish oil supplements, probiotic supplements, and greens powder mix 2 weeks prior to starting the study, and willing to maintain the washout for the duration of the study (14 weeks).
  • Willing and able to consume study product as directed daily for about 12 weeks
  • Willing to track consumption of study product
  • Willing to implement changes to diet, exercise, and sleep habits for 12 weeks
  • Willing to avoid alcohol, recreational drugs, and smoking/vaping for the duration of the study (approximately 12 weeks)
  • Own a smartphone or tablet and willing to download the fitness tracker app
  • Willing to wear a fitness tracker for the duration of the study (approximately 12 weeks)
  • At least 110 pounds
  • No metabolic disease (BMI>35, diagnosis and treatment of
  • hypertension, diabetes, or dyslipidemia)
  • No major diseases under treatment by doctor (Medical Reviewer's
  • discretion)
  • No pregnancy within the last 60 days or currently breastfeeding
  • (females)
  • No allergy to any of the ingredients in the study products
  • No regular internal consumption of the study products within the last 1 month (regularly is defined as dosing daily for more than 2 consecutive weeks, or dosing more than 2-3 times per week for 4 consecutive weeks)
  • No alcohol, recreational drug, or smoking/vaping use in the past 1 month
  • No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk or affect study results, procedures, or outcomes
  • Not currently or previously participating in any other clinical trial within the last 30 calendar days

Exclusion criteria

  • Failure to meet all listed inclusion criteria

Treatment and study plan

Supplement system + copaiba softgels

Dietary Supplement

The supplement system consists of:

  • dōTERRA VMG+ Whole-Food Nutrient Complex (VMG) sachets
  • dōTERRA EO Mega+ Essential Oil Omega Complex (EOM) softgels
  • dōTERRA PB Restore ProBiome Complex (PBR) capsules

Which will also be taken with:

  • dōTERRA Copaiba Essential Oil (CEO) softgels

VMG is a powdered nutritional drink packaged in individual sachets. The powder is a blend of food powders/extracts, vitamins and minerals, probiotics, essential oils, and sweeteners.

EOM is a softgel containing fish oil and wild orange essential oil.

PBR is a capsule containing a mix of pre-, pro-, and post-biotics and bacteriophages.

CEO is a softgel containing Copaifera (copaiba) essential oil and extra virgin olive oil.

Participants will also be asked to implement lifestyle changes. They will be asked to try to get at least 8 hours of sleep, eat at least three servings of fruit/vegetables daily, and exercise at least 30 minutes every day.

Supplement system + placebo softgels

Dietary Supplement

The supplement system consists of:

  • dōTERRA VMG+ Whole-Food Nutrient Complex (VMG) sachets
  • dōTERRA EO Mega+ Essential Oil Omega Complex (EOM) softgels
  • dōTERRA PB Restore ProBiome Complex (PBR) capsules

Which will also be taken with:

  • Olive oil placebo softgels

VMG is a powdered nutritional drink packaged in individual sachets. The powder is a blend of food powders/extracts, vitamins and minerals, probiotics, essential oils, and sweeteners.

EOM is a softgel containing fish oil and wild orange essential oil.

PBR is a capsule containing a mix of pre-, pro-, and post-biotics and bacteriophages.

The placebo is a softgel containing extra virgin olive oil.

Participants will also be asked to implement lifestyle changes. They will be asked to try to get at least 8 hours of sleep, eat at least three servings of fruit/vegetables daily, and exercise at least 30 minutes every day.

Primary outcomes

  1. Gene expression

    Time frame: 12 weeks

    Gene expression analysis refers to a genome-wide quantification of methylation. EPIC850k array will be used for methylation analysis. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.

  2. Vitamin D 25-hydroxy (ng/mL)

    Time frame: 12 weeks

    Serum marker for Vitamin D levels

  3. High sensitivity C-reactive protein (mg/L)

    Time frame: 12 weeks

    Serum marker for hsCRP levels

Secondary outcomes

  1. Albumin (g/dL)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  2. Blood urea nitrogen (BUN) (mg/dL)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  3. Creatinine (mg/dL)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  4. Alkaline phosphatase (U/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  5. Alanine transaminase (ALT) (U/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  6. Aspartate aminotransferase (AST) (U/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  7. Calcium (mg/dL)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  8. Carbon Dioxide (mmol/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  9. Chloride (mmol/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  10. Potassium (mmol/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  11. Sodium (mmol/L)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  12. Total bilirubin (mg/dL)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  13. Total protein (g/dL)

    Time frame: 12 weeks

    Item in comprehensive metabolic panel for safety assessment

  14. White blood cells (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  15. Red blood cells (x10E6/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  16. Hemoglobin (g/dL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  17. Hematocrit (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  18. Mean corpuscular volume (fL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  19. Mean corpuscular hemoglobin concentration (g/dL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  20. Red cell distribution width (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  21. Platelets (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  22. Neutrophils (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  23. Monocytes (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  24. Eosinophils (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  25. Basophils (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  26. Neutrophils (Absolute) (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  27. Lymphocytes (Absolute) (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  28. Monocytes (Absolute) (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  29. Eosinophils (Absolute) (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  30. Basophils (Absolute) (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  31. Immature granulocytes (%)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  32. Immature granulocytes (Absolute) (x10E3/uL)

    Time frame: 12 weeks

    Item in complete blood count for safety assessment

  33. Adverse events

    Time frame: 12 weeks

    This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology/urine analyses.

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

    Time frame: 12 weeks

    Validated, self-reported scale for the measurement of anxiety severity. The GAD-7 is a 7-item scale with total scores between 0 and 21. Higher scores indicate higher anxiety severity.

  35. Patient Health Questionnaire (PHQ-8) scale

    Time frame: 12 weeks

    Validated, self-reported scale for the measurement of depression severity. The PHQ-8 is an 8-item scale with total scores between 0 and 12. Higher scores indicate higher depression severity.

  36. Leeds Sleep Evaluation Questionnaire (LSEQ) scale

    Time frame: 12 weeks

    Validated, self-reported scale for the measurement of sleep quality. The LSEQ is a 10-item scale. Each item is scored 0 to 100. Higher scores indicate better sleep quality.

  37. Short Form-20 (SF-20) scale

    Time frame: 12 weeks

    Validated, self-reported scale for the assessment of subjective quality of life. The SF-20 is a 20-item scale. Each item is scored 0-100. Higher scores indicate better subjective quality of life.

  38. Digestion-associated Quality of Life Questionnaire (DQLQ)

    Time frame: 12 weeks

    Validated, self-reported scale for the measurement of digestion-associated quality of life outcomes. The DQLQ is a 9-item scale with total scores between 0 and 9. Each item is scored as a percentage 0-100, with 100 representing a score of 1. Higher scores indicate greater dissatisfaction with digestion-associated quality of life outcomes.

  39. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 12 weeks

    Validated, self-reported scale for the assessment of gastrointestinal symptoms and how much discomfort they cause. The GSRS consists of 15 items scored between 1 and 7 each. Higher scores indicate more severe symptoms.

  40. Digit Symbol Substitution Test (DSST)

    Time frame: 12 weeks

    A timed test that measures psychomotor performance and cognitive function. The test taker is given a key grid of numbers and matching symbols, and a list of numbers and empty boxes. The test taker matches the symbols to the numbers in the empty boxes within the allowed time (90 seconds). Participants will be scored according to the number of symbols they correctly correlate with a number.

  41. Word Recall Test (WRT)

    Time frame: 12 weeks

    A timed memory assessment that asks the test taker to recall a list of words. The test administrator reads a list of 15 words, and the test taker is asked to immediately write down all the words they remember. After 15 minutes, the test taker is asked to write down the words again. Participants will be scored based on the number of words they recall immediately and after 15 minutes.

  42. Functional movement test

    Time frame: 12 weeks

    Functional Movement Test (FMT) is an assessment used to evaluate an individual's movement patterns, mobility, stability, and overall functional fitness. It consists of several fundamental movement tests designed to identify weaknesses, imbalances, or limitations in a person's functional ability. During an FMT, a person is asked to perform movements such as directional neck movements, arm reaches, squats, push-ups, and balance on one leg. Each movement is scored based on form and control.

  43. Gut microbiome test

    Time frame: 12 weeks

    Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type)

  44. Total steps

    Time frame: 12 weeks

    Daily number of steps measured with fitness trackers.

  45. Sleep score

    Time frame: 12 weeks

    A personalized score, ranging from 1 to 100, that reflects quality of sleep based on factors like time asleep, deep and REM sleep.

  46. Body mass index (BMI)

    Time frame: 12 weeks

    A calculation of body fat based on height and weight

  47. Body mass percentage (%)

    Time frame: 12 weeks

    An estimation of bone, fat, muscle, and water mass %

  48. Blood pressure (mmHg)

    Time frame: 12 weeks

    The force of blood pushing against the walls of arteries.

  49. Heart rate (BPM)

    Time frame: 12 weeks

    The number of heart beats per minute

  50. Waist circumference (cm)

    Time frame: 12 weeks

    The circumference of the waist measured at the thinnest point of the waist

  51. Insulin (uIU/mL)

    Time frame: 12 weeks

    Serum marker used to determine insulin levels

  52. Sex hormone binding globulin (nmol/L)

    Time frame: 12 weeks

    Serum marker used to determine SHBG (Sex Hormone Binding Globulin) levels

  53. Testosterone (ng/dL)

    Time frame: 12 weeks

    Serum marker used to determine testosterone levels

  54. Thyroxine (T4) (ng/dL)

    Time frame: 12 weeks

    Serum marker used to determine thyroxine (T4) levels

  55. Thyroglobulin antibody (IU/mL)

    Time frame: 12 weeks

    Serum marker used to determine thyroglobulin antibody levels

  56. Thyroid peroxidase antibody (IU/mL)

    Time frame: 12 weeks

    Serum marker used to determine thyroid peroxidase antibody levels

  57. Vitamin B12 (pg/mL)

    Time frame: 12 weeks

    Serum marker used to determine Vitamin B12 levels

  58. Ferritin (ng/mL)

    Time frame: 12 weeks

    Serum marker used to determine ferritin levels

  59. Gamma-glutamyl transferase (GGT)

    Time frame: 12 weeks

    Serum marker used to determine GGT levels

  60. Transferritin saturation

    Time frame: 12 weeks

    Serum test used to determine UIBC, TIBC, Iron, Fe Saturation%

  61. Total sleep (minutes)

    Time frame: 12 weeks

    Total number of minutes asleep, as measured by fitness tracker.

  62. Light sleep (%)

    Time frame: 12 weeks

    The percentage of time asleep spent in light sleep, as measured by fitness tracker.

  63. Deep sleep (%)

    Time frame: 12 weeks

    The percentage of time asleep spent in deep sleep, as measured by fitness tracker.

  64. REM sleep (%)

    Time frame: 12 weeks

    The percentage of time asleep spent in deep sleep, as measured by fitness tracker.

  65. Active minutes

    Time frame: 12 weeks

    Number of daily active minutes as measured by fitness tracker.

  66. Sedentary minutes

    Time frame: 12 weeks

    Number of daily sedentary minutes as measured by fitness tracker.

  67. Active calories burned

    Time frame: 12 weeks

    Number of daily active calories burned as measured by fitness tracker.

  68. Total calories burned

    Time frame: 12 weeks

    Number of daily total calories burned as measured by fitness tracker.

Sponsors and collaborators

Lead sponsor

dōTERRA International

Industry

Registry information

Official study title

Wellness and Epigenetic Impact of a Natural Product Supplement System Combined With Lifestyle Modification

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Mar 10, 2026

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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