Natural Product System and Lifestyle Modification

NCT ID: NCT06931977

Last Updated: 2025-05-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2025-09-30

Brief Summary

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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?

Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Participants and investigators will be masked to whether the participants receive the copaiba essential oil or placebo, but will know the identity of the other three supplements they take.

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.

Group Type EXPERIMENTAL

Supplement system + copaiba softgels

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Supplement system + placebo softgels

Intervention Type 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.

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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dōTERRA International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicole Stevens, PhD

Role: CONTACT

8016157200

Russell Osguthorpe, MD

Role: CONTACT

8016157200

Facility Contacts

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Nicole Stevens, PhD

Role: primary

8016157200

Other Identifiers

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DO-125023-FWS

Identifier Type: -

Identifier Source: org_study_id

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