Natural Product System and Lifestyle Modification

dōTERRA

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Supplement system + placebo softgels; Dietary Supplement: Supplement system + copaiba softgels

Study type: Interventional

Funder types: Industry

Identifiers

NCT06931977

DO-125023-FWS

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Failure to meet all listed inclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Supplement System + Copaiba softgels

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Supplement system + copaiba softgels

Supplement System + placebo softgels

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Supplement system + placebo softgels