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HealthyNCT06931977

Natural Product System and Lifestyle Modification

A study testing Supplement system + copaiba softgels in people with Healthy, run by dōTERRA International at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Supplement system + copaiba softgels
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
1 siteUnited States
Study dates
29 Apr 2025to 3 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).
Show all 24Show fewer
  • 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

Who cannot join

  • Failure to meet all listed inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • doTERRA International

    Pleasant Grove, Utah, 84062

Other trials in United States

About this study

Official title: Wellness and Epigenetic Impact of a Natural Product Supplement System Combined With 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?
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.

Conditions
Healthy
Being tested
Supplement system + copaiba softgels, Supplement system + placebo softgels
Keywords
Gene expression, Essential oil, Copaiba, Omega 3, Probiotic, Greens powder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supplement system + copaiba softgelsDietary 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 softgelsDietary 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.

Study groups in NCT06931977
Study groupRoleWhat they receive
Supplement System + Copaiba softgelsExperimentalParticipants 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.
Receives: Dietary Supplement: Supplement system + copaiba softgels
Supplement System + placebo softgelsPlacebo comparatorParticipants 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.
Receives: Dietary Supplement: Supplement system + placebo softgels

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

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

    Serum marker for Vitamin D levels

    Measured: 12 weeks

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

    Serum marker for hsCRP levels

    Measured: 12 weeks

Secondary outcomes (68)
  1. Albumin (g/dL)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

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

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  3. Creatinine (mg/dL)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  4. Alkaline phosphatase (U/L)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

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

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

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

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  7. Calcium (mg/dL)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  8. Carbon Dioxide (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  9. Chloride (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  10. Potassium (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  11. Sodium (mmol/L)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  12. Total bilirubin (mg/dL)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  13. Total protein (g/dL)

    Item in comprehensive metabolic panel for safety assessment

    Measured: 12 weeks

  14. White blood cells (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  15. Red blood cells (x10E6/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  16. Hemoglobin (g/dL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  17. Hematocrit (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  18. Mean corpuscular volume (fL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  19. Mean corpuscular hemoglobin concentration (g/dL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  20. Red cell distribution width (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  21. Platelets (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  22. Neutrophils (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  23. Monocytes (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  24. Eosinophils (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  25. Basophils (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  26. Neutrophils (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  27. Lymphocytes (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  28. Monocytes (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  29. Eosinophils (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  30. Basophils (Absolute) (x10E3/uL)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

  31. Immature granulocytes (%)

    Item in complete blood count for safety assessment

    Measured: 12 weeks

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

    Item in complete blood count for safety assessment

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 12 weeks

  43. Gut microbiome test

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

    Measured: 12 weeks

  44. Total steps

    Daily number of steps measured with fitness trackers.

    Measured: 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.

    Measured: 12 weeks

  46. Body mass index (BMI)

    A calculation of body fat based on height and weight

    Measured: 12 weeks

  47. Body mass percentage (%)

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

    Measured: 12 weeks

  48. Blood pressure (mmHg)

    The force of blood pushing against the walls of arteries.

    Measured: 12 weeks

  49. Heart rate (BPM)

    The number of heart beats per minute

    Measured: 12 weeks

  50. Waist circumference (cm)

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

    Measured: 12 weeks

  51. Insulin (uIU/mL)

    Serum marker used to determine insulin levels

    Measured: 12 weeks

  52. Sex hormone binding globulin (nmol/L)

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

    Measured: 12 weeks

  53. Testosterone (ng/dL)

    Serum marker used to determine testosterone levels

    Measured: 12 weeks

  54. Thyroxine (T4) (ng/dL)

    Serum marker used to determine thyroxine (T4) levels

    Measured: 12 weeks

  55. Thyroglobulin antibody (IU/mL)

    Serum marker used to determine thyroglobulin antibody levels

    Measured: 12 weeks

  56. Thyroid peroxidase antibody (IU/mL)

    Serum marker used to determine thyroid peroxidase antibody levels

    Measured: 12 weeks

  57. Vitamin B12 (pg/mL)

    Serum marker used to determine Vitamin B12 levels

    Measured: 12 weeks

  58. Ferritin (ng/mL)

    Serum marker used to determine ferritin levels

    Measured: 12 weeks

  59. Gamma-glutamyl transferase (GGT)

    Serum marker used to determine GGT levels

    Measured: 12 weeks

  60. Transferritin saturation

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

    Measured: 12 weeks

  61. Total sleep (minutes)

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

    Measured: 12 weeks

  62. Light sleep (%)

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

    Measured: 12 weeks

  63. Deep sleep (%)

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

    Measured: 12 weeks

  64. REM sleep (%)

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

    Measured: 12 weeks

  65. Active minutes

    Number of daily active minutes as measured by fitness tracker.

    Measured: 12 weeks

  66. Sedentary minutes

    Number of daily sedentary minutes as measured by fitness tracker.

    Measured: 12 weeks

  67. Active calories burned

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

    Measured: 12 weeks

  68. Total calories burned

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2025
  2. Study start29 Apr 2025
  3. Primary completion3 Sep 2025
  4. Study completion3 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06931977
Sponsor's protocol ID
DO-125023-FWS
Status last verified
Mar 2026
First submitted
2 Apr 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Supplement system + copaiba softgels in people with Healthy, run by dōTERRA International at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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