RECRUITING

Natural Product System and Lifestyle Modification

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Conditions

HealthyGene expressionEssential oilCopaibaOmega 3ProbioticGreens powder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Wellness and Epigenetic Impact of a Natural Product Supplement System Combined With Lifestyle Modification

Quick Facts

Study Start:2025-04-29
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06931977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ages 30-55 years old
  2. * Willing to attend three study visits at Prime Meridian Health Clinic in Pleasant Grove, Utah
  3. * Willing and able to undergo three blood draws over 12 weeks
  4. * Willing to provide urine and stool samples three times over 12 weeks
  5. * 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).
  6. * 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).
  7. * Willing and able to consume study product as directed daily for about 12 weeks
  8. * Willing to track consumption of study product
  9. * Willing to implement changes to diet, exercise, and sleep habits for 12 weeks
  10. * Willing to avoid alcohol, recreational drugs, and smoking/vaping for the duration of the study (approximately 12 weeks)
  11. * Own a smartphone or tablet and willing to download the fitness tracker app
  12. * Willing to wear a fitness tracker for the duration of the study (approximately 12 weeks)
  13. * At least 110 pounds
  14. * No metabolic disease (BMI\>35, diagnosis and treatment of
  15. * hypertension, diabetes, or dyslipidemia)
  16. * No major diseases under treatment by doctor (Medical Reviewer's
  17. * discretion)
  18. * No pregnancy within the last 60 days or currently breastfeeding
  19. * (females)
  20. * No allergy to any of the ingredients in the study products
  21. * 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)
  22. * No alcohol, recreational drug, or smoking/vaping use in the past 1 month
  23. * 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
  24. * Not currently or previously participating in any other clinical trial within the last 30 calendar days
  1. * Failure to meet all listed inclusion criteria

Contacts and Locations

Study Contact

Nicole Stevens, PhD
CONTACT
8016157200
nstevens@doterra.com
Russell Osguthorpe, MD
CONTACT
8016157200
rosguthorpe@doterra.com

Principal Investigator

Nicole Stevens, PhD
PRINCIPAL_INVESTIGATOR
doTERRA International LLC

Study Locations (Sites)

doTERRA International
Pleasant Grove, Utah, 84062
United States

Collaborators and Investigators

Sponsor: dōTERRA International

  • Nicole Stevens, PhD, PRINCIPAL_INVESTIGATOR, doTERRA International LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2025-09

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Gene expression
  • Essential oil
  • Copaiba
  • Omega 3
  • Probiotic
  • Greens powder

Additional Relevant MeSH Terms

  • Healthy