Natural Product System and Lifestyle Modification

NCT06931977 | Completed

• 1 other identifier: DO-125023-FWS
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.How does daily ingestion of dietary supplements affect gene expression and hsCRP and vitamin D levels measured in blood?
2. 2.How does daily ingestion of dietary supplements affect anthropometric measurements, sleep and physical activity, and gut microbiome composition?
3. 3.How does daily ingestion of dietary supplements affect cognitive and subjective health parameters?
4. 4.Do prescriptive lifestyle modifications affect the supplements' efficacy?
5. 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. 6.Is ingesting dietary supplements for 12 weeks safe, as measured by laboratory tests and adverse events?

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Gene expression

  Gene expression analysis refers to a genome-wide quantification of methylation. EPIC850k array will be used for methylation analysis. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.

  12 weeks

• Vitamin D 25-hydroxy (ng/mL)

  Serum marker for Vitamin D levels

  12 weeks

• High sensitivity C-reactive protein (mg/L)

  Serum marker for hsCRP levels

  12 weeks

Secondary Outcomes (68)

• Albumin (g/dL)

  12 weeks

• Blood urea nitrogen (BUN) (mg/dL)

  12 weeks

• Creatinine (mg/dL)

  12 weeks

• Alkaline phosphatase (U/L)

  12 weeks

• Alanine transaminase (ALT) (U/L)

  12 weeks

Study Arms (2)

Supplement System + Copaiba softgels

EXPERIMENTAL

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.

Dietary Supplement: Supplement system + copaiba softgels

Supplement System + placebo softgels

PLACEBO COMPARATOR

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.

Dietary Supplement: Supplement system + placebo softgels

Interventions

Supplement system + copaiba softgels 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 + Copaiba softgels

Supplement system + placebo softgels 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.

Supplement System + placebo softgels

Eligibility Criteria

• Age: 30 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• dōTERRA International: lead

Study Sites (1)

doTERRA International

Pleasant Grove, Utah, 84062, United States

Location

Study Officials

• Nicole Stevens, PhD

  doTERRA International LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 17, 2025
• Study Start: April 29, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)