Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-04-29
2025-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Supplement 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.
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.
Supplement 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.
Interventions
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Supplement 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.
Supplement 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.
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
55 Years
ALL
Yes
Sponsors
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dōTERRA International
INDUSTRY
Responsible Party
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Principal Investigators
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Nicole Stevens, PhD
Role: PRINCIPAL_INVESTIGATOR
doTERRA International LLC
Locations
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doTERRA International
Pleasant Grove, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DO-125023-FWS
Identifier Type: -
Identifier Source: org_study_id
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