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

Trial Summary

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 the Supplement System for Healthy Subjects generally safe for humans?

Research on natural health products and dietary supplements shows that adverse events can occur, such as diarrhea and vomiting, with certain ingredients like Coleus forskohlii and dietary fiber. While not all supplements cause issues, it's important to be cautious and aware of potential side effects. ^{1 2 3 4 5}

How is the Natural Product System treatment different from other treatments for this condition?

The Natural Product System is unique because it is a dietary supplement, which means it is designed to add nutrients and other beneficial substances to a person's diet, unlike standard medications that are often used to treat specific conditions. This treatment may include a variety of natural ingredients, such as vitamins, minerals, and herbal products, which are not typically found in conventional drug therapies. ^{6 7 8 9 10}

What is the purpose of this trial?

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?

Research Team

Nicole Stevens, PhD

Principal Investigator

doTERRA International LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Nationwide Online Survey Method to Estimate Ongoing Adverse Events Caused by Supplement Use: Application to Diarrhea]. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. [2010]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary supplement users: demographics, product use, and medical system interaction. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

[Dietary supplements--evaluation of patient inquiries at a drug information service]. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Dietary Supplement Label Database in Italy: Focus of FoodEx2 Coding. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and performance benefits of arginine supplements for military personnel: a systematic review. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Prevalence of Dietary Supplement Use by Athletes: Systematic Review and Meta-Analysis. [2022]