CClinicalTrials.gg
CompletedNCT06931977Updated Mar 10, 2026

Natural Product System and Lifestyle Modification

An interventional study of Supplement system + copaiba softgels and Supplement system + placebo softgels in Healthy, sponsored by dōTERRA International. Completed at 1 site in United States. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by dōTERRA International · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study summary

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?
Read the detailed description

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.

02

Conditions studied

  • Healthy

Keywords

  • Gene expression
  • Essential oil
  • Copaiba
  • Omega 3
  • Probiotic
  • Greens powder
03

In context

Lead sponsor

dōTERRA International is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Failure to meet all listed inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    Supplement System + Copaiba softgels

    Participants in this arm will take one VMG sachet, three EOM softgels, and one copaiba softgel in the morning with food. At least eight hours later, they will take one PBR capsule and one copabia softgel with food. They will follow this dosing regimen every day for 12 weeks.

    Dietary Supplement: Supplement system + copaiba softgels

  • Placebo comparator
    Supplement System + placebo softgels

    Participants in this arm will take one VMG sachet, three EOM softgels, and one placebo softgel in the morning with food. At least eight hours later, they will take one PBR capsule and one placebo softgel with food. They will follow this dosing regimen every day for 12 weeks.

    Dietary Supplement: Supplement system + placebo softgels

Interventions

  • Dietary supplementSupplement system + copaiba softgels

    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.

  • Dietary supplementSupplement system + placebo softgels

    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.

06

What researchers measure

Primary outcomes

  1. Gene expression

    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.

    Time frame: 12 weeks

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

    Serum marker for Vitamin D levels

    Time frame: 12 weeks

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

    Serum marker for hsCRP levels

    Time frame: 12 weeks

Secondary outcomes

  1. Albumin (g/dL)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

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

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  3. Creatinine (mg/dL)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  4. Alkaline phosphatase (U/L)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

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

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

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

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  7. Calcium (mg/dL)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  8. Carbon Dioxide (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  9. Chloride (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  10. Potassium (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  11. Sodium (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  12. Total bilirubin (mg/dL)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  13. Total protein (g/dL)

    Item in comprehensive metabolic panel for safety assessment

    Time frame: 12 weeks

  14. White blood cells (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  15. Red blood cells (x10E6/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  16. Hemoglobin (g/dL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  17. Hematocrit (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  18. Mean corpuscular volume (fL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  19. Mean corpuscular hemoglobin concentration (g/dL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  20. Red cell distribution width (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  21. Platelets (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  22. Neutrophils (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  23. Monocytes (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  24. Eosinophils (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  25. Basophils (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  26. Neutrophils (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  27. Lymphocytes (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  28. Monocytes (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  29. Eosinophils (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  30. Basophils (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  31. Immature granulocytes (%)

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

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

    Item in complete blood count for safety assessment

    Time frame: 12 weeks

  33. Adverse events

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

    Time frame: 12 weeks

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

    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.

    Time frame: 12 weeks

  35. Patient Health Questionnaire (PHQ-8) scale

    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.

    Time frame: 12 weeks

  36. Leeds Sleep Evaluation Questionnaire (LSEQ) scale

    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.

    Time frame: 12 weeks

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

    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.

    Time frame: 12 weeks

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

    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.

    Time frame: 12 weeks

  39. Gastrointestinal Symptom Rating Scale (GSRS)

    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.

    Time frame: 12 weeks

  40. Digit Symbol Substitution Test (DSST)

    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.

    Time frame: 12 weeks

  41. Word Recall Test (WRT)

    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.

    Time frame: 12 weeks

  42. Functional movement test

    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.

    Time frame: 12 weeks

  43. Gut microbiome test

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

    Time frame: 12 weeks

  44. Total steps

    Daily number of steps measured with fitness trackers.

    Time frame: 12 weeks

  45. Sleep score

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

    Time frame: 12 weeks

  46. Body mass index (BMI)

    A calculation of body fat based on height and weight

    Time frame: 12 weeks

  47. Body mass percentage (%)

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

    Time frame: 12 weeks

  48. Blood pressure (mmHg)

    The force of blood pushing against the walls of arteries.

    Time frame: 12 weeks

  49. Heart rate (BPM)

    The number of heart beats per minute

    Time frame: 12 weeks

  50. Waist circumference (cm)

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

    Time frame: 12 weeks

  51. Insulin (uIU/mL)

    Serum marker used to determine insulin levels

    Time frame: 12 weeks

  52. Sex hormone binding globulin (nmol/L)

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

    Time frame: 12 weeks

  53. Testosterone (ng/dL)

    Serum marker used to determine testosterone levels

    Time frame: 12 weeks

  54. Thyroxine (T4) (ng/dL)

    Serum marker used to determine thyroxine (T4) levels

    Time frame: 12 weeks

  55. Thyroglobulin antibody (IU/mL)

    Serum marker used to determine thyroglobulin antibody levels

    Time frame: 12 weeks

  56. Thyroid peroxidase antibody (IU/mL)

    Serum marker used to determine thyroid peroxidase antibody levels

    Time frame: 12 weeks

  57. Vitamin B12 (pg/mL)

    Serum marker used to determine Vitamin B12 levels

    Time frame: 12 weeks

  58. Ferritin (ng/mL)

    Serum marker used to determine ferritin levels

    Time frame: 12 weeks

  59. Gamma-glutamyl transferase (GGT)

    Serum marker used to determine GGT levels

    Time frame: 12 weeks

  60. Transferritin saturation

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

    Time frame: 12 weeks

  61. Total sleep (minutes)

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

    Time frame: 12 weeks

  62. Light sleep (%)

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

    Time frame: 12 weeks

  63. Deep sleep (%)

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

    Time frame: 12 weeks

  64. REM sleep (%)

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

    Time frame: 12 weeks

  65. Active minutes

    Number of daily active minutes as measured by fitness tracker.

    Time frame: 12 weeks

  66. Sedentary minutes

    Number of daily sedentary minutes as measured by fitness tracker.

    Time frame: 12 weeks

  67. Active calories burned

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

    Time frame: 12 weeks

  68. Total calories burned

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

    Time frame: 12 weeks

07

Study locations

1 site
  • doTERRA International
    Pleasant Grove, Utah 84062, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06931977
Lead sponsor
dōTERRA International
Responsible party
Sponsor
First posted
Apr 17, 2025
Start date
Apr 29, 2025
Primary completion
Sep 3, 2025
Completion
Sep 3, 2025
Last update
Mar 10, 2026

Study contacts

Nicole Stevens, PhD
principal investigator · doTERRA International LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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