Supplement System for Healthy Subjects

Overseen By Nicole Stevens, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: dōTERRA International

Disqualifiers: Metabolic disease, Major diseases, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dietary supplements and lifestyle changes impact the body and mind. Researchers aim to determine if these supplements affect gene activity, blood markers like vitamin D, physical health, sleep, and gut health. The study will compare the effects of taking all four supplements versus three supplements with a placebo, a harmless pill resembling the real thing. Individuals who are generally healthy, weigh at least 110 pounds, and do not have major diseases or metabolic conditions might be suitable candidates. Participants should be prepared to make lifestyle changes, attend study visits, and track their supplement intake. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of supplements and lifestyle changes.

Will I have to stop taking my current medications?

The trial requires participants to stop taking all internally consumed essential oils, botanical products, fish oil supplements, probiotic supplements, and greens powder mix at least 2 weeks before starting and for the duration of the study. The protocol does not specify other medications, so it's best to consult with the study team for guidance on other medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that copaiba softgels, one of the supplements in this trial, are generally easy to swallow and well-tolerated. Manufactured by doTERRA, these softgels are safe for internal use.

The study aims to determine the safety of taking these supplements daily for 12 weeks. Although specific data on side effects from past studies is lacking, the trial is in the "Not Applicable" phase, indicating that the treatment is not expected to cause significant harm. This phase often involves healthy volunteers to evaluate basic safety.

Researchers will closely monitor participants for any side effects, assessing safety through lab tests and reports of any issues. With these precautions, the trial aims to ensure the supplements do not pose a significant risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Supplement System because it combines natural ingredients like copaiba, known for its potential anti-inflammatory properties, with a carefully timed dosing regimen. Unlike standard over-the-counter supplements, which often lack specific timing or combination protocols, this system uses a unique blend of VMG sachets, EOM softgels, and PBR capsules to optimize absorption and efficacy. The inclusion of copaiba softgels is particularly intriguing, as they offer a new mechanism compared to typical supplements, potentially enhancing the body's natural defenses and supporting overall health.

What evidence suggests that this trial's treatments could be effective for healthy subjects?

Research has shown that natural products, such as those in the Supplement System, can offer various health benefits. In this trial, participants will receive either the Supplement System with Copaiba softgels or the Supplement System with placebo softgels. Studies have found that these natural products can positively affect gene expression and certain blood tests. For example, some supplements may help with leg discomfort. Combining different natural ingredients can also support overall health. Although specific data on this exact combination is limited, the ingredients are generally considered safe and beneficial for health. ^{5 6 7 8 9}

Who Is on the Research Team?

Nicole Stevens, PhD

Principal Investigator

doTERRA International LLC

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in how dietary supplements and lifestyle changes might affect their health. Participants should be willing to take supplements, make lifestyle adjustments, and undergo regular blood tests. Specific eligibility criteria are not provided.

Inclusion Criteria

I am between 30 and 55 years old.

I am willing to give urine and stool samples three times in 12 weeks.

Willing to attend three study visits at Prime Meridian Health Clinic in Pleasant Grove, Utah

Exclusion Criteria

Failure to meet all listed inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary supplements and follow lifestyle modifications for 12 weeks

12 weeks

Daily regimen with regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Natural Product System

Trial Overview The study is testing the impact of a supplement system combined with either placebo or copaiba softgels on gene expression, inflammation markers like hsCRP, vitamin D levels, body measurements, sleep and activity patterns, gut health, cognition and subjective well-being over 12 weeks.

How Is the Trial Designed?

Group I: Supplement System + Copaiba softgels Experimental Treatment 1 Intervention

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 II: Supplement System + placebo softgels Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

dōTERRA International

Lead Sponsor

Trials

7

Recruited

580+

Published Research Related to This Trial

Approximately 70% of military personnel use dietary supplements, which is significantly higher than the 50% usage rate in the general civilian population, potentially increasing their risk of adverse events.

The US Department of Defense has implemented measures like Operation Supplement Safety to educate military personnel about safe supplement use and to monitor and report adverse events associated with dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. Deuster, PA., Lieberman, HR.[2017]

A study involving 78,220 dietary supplement users found that 9% to 25% reported experiencing adverse events, with a focus on diarrhea as a common symptom.

Online surveys proved to be an effective method for identifying adverse events related to dietary supplements, particularly highlighting that herbal ingredients like Coleus forskohlii were frequently associated with diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nationwide Online Survey Method to Estimate Ongoing Adverse Events Caused by Supplement Use: Application to Diarrhea]. Nishijima, C., Chiba, T., Sato, Y., et al.[2021]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

In a study involving 1118 patients across 10 community pharmacies, it was found that 58.8% of patients were using both prescription drugs and natural health products (NHPs) concurrently, which significantly increased their risk of experiencing adverse events (AEs).

Patients using both prescription drugs and NHPs were 6.4 times more likely to report an AE compared to those using only prescription drugs, highlighting the importance of monitoring concurrent use for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. Necyk, C., Tsuyuki, RT., Boon, H., et al.[2022]

The Korea Food & Drug Administration (KFDA) established an adverse event (AE) monitoring system for dietary supplements, collecting 1430 AE reports from 2006 to 2008, with 222 providing complete case details for analysis.

The monitoring identified a potential signal linking dietary fiber to vomiting, but due to insufficient data, the KFDA could not confirm a causal relationship, indicating the need for further investigation into this concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. Park, KS., Kwon, O.[2010]

Citations

1. withpower.com withpower.com/trial/phase-healthy-subjects-hs-4-2025-98335

Supplement System for Healthy Subjects In a study involving 1118 patients across 10 community pharmacies, it was found that 58.8% of patients were using both prescription drugs and natural health ...

2. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-025-01184-1

A nutraceutical intervention for alleviating tired and heavy legs ... Based on this finding, we investigated the efficacy of a food supplement containing this nutraceutical ingredient in alleviating leg discomforts ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624003560

The Evolution of Science and Regulation of Dietary ... The science surrounding dietary supplements has evolved substantially over the last few decades since their formal regulation in 1994.

4. nccih.nih.gov nccih.nih.gov/grants/nutritional-interventions-and-natural-products-research-information-for-researchers

Natural Products Research—Information for Researchers - nccih Information for researchers about NCCIH's priorities and funding opportunities for research on natural products, including criteria for determining when ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10346460/

Functional Properties of Natural Products and Human Health A plethora of basic in vitro and in vivo studies have also unraveled molecular mechanisms underlying NPs' health benefits [1]. In this Special Issue, eighteen ...

6. capteksoftgel.com capteksoftgel.com/products/

CAPTEK® Softgel International, Inc. | Products Easy to swallow, safe, and tamper evident. Pure, clear and elegant appearance with no taste or odor. Well suited for Halal or Kosher certification. Available in ...

7. doterra.com doterra.com/US/en/p/copaiba-softgels

Copaiba Softgels | doTERRA Essential Oils Copaiba Softgels are easy-to-swallow tapioca capsules that provide a convenient way to enjoy the internal benefits of Copaiba essential oil.*.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10469777/

A comparative absorption study of sucrosomial® ... We aimed to compare the absorption of an innovative phospholipids-sucrester matrix biodelivery vehicle-based (sucrosomial ® ) orodispersible Vit D3 preparation

9. clinicaltrials.gov clinicaltrials.gov/study/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 ...