Natural Product System and Lifestyle Modification

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Supplement system + copaiba softgels; Dietary supplement: Supplement system + placebo softgels

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • dōTERRA International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplement System + Copaiba softgels; 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; 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.
Placebo Comparator: Supplement System + placebo softgels; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin (g/dL)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Blood urea nitrogen (BUN) (mg/dL)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Creatinine (mg/dL)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Alkaline phosphatase (U/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Alanine transaminase (ALT) (U/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Aspartate aminotransferase (AST) (U/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Calcium (mg/dL)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Carbon Dioxide (mmol/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Chloride (mmol/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Potassium (mmol/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Sodium (mmol/L)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Total bilirubin (mg/dL)	Item in comprehensive metabolic panel for safety assessment	12 weeks
Total protein (g/dL)	Item in comprehensive metabolic panel for safety assessment	12 weeks
White blood cells (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Red blood cells (x10E6/uL)	Item in complete blood count for safety assessment	12 weeks
Hemoglobin (g/dL)	Item in complete blood count for safety assessment	12 weeks
Hematocrit (%)	Item in complete blood count for safety assessment	12 weeks
Mean corpuscular volume (fL)	Item in complete blood count for safety assessment	12 weeks
Mean corpuscular hemoglobin concentration (g/dL)	Item in complete blood count for safety assessment	12 weeks
Red cell distribution width (%)	Item in complete blood count for safety assessment	12 weeks
Platelets (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Neutrophils (%)	Item in complete blood count for safety assessment	12 weeks
Monocytes (%)	Item in complete blood count for safety assessment	12 weeks
Eosinophils (%)	Item in complete blood count for safety assessment	12 weeks
Basophils (%)	Item in complete blood count for safety assessment	12 weeks
Neutrophils (Absolute) (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Lymphocytes (Absolute) (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Monocytes (Absolute) (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Eosinophils (Absolute) (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Basophils (Absolute) (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Immature granulocytes (%)	Item in complete blood count for safety assessment	12 weeks
Immature granulocytes (Absolute) (x10E3/uL)	Item in complete blood count for safety assessment	12 weeks
Adverse events	This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology/urine analyses.	12 weeks
Generalized Anxiety Disorder-7 (GAD-7) scale	Validated, self-reported scale for the measurement of anxiety severity. The GAD-7 is a 7-item scale with total scores between 0 and 21. Higher scores indicate higher anxiety severity.	12 weeks
Patient Health Questionnaire (PHQ-8) scale	Validated, self-reported scale for the measurement of depression severity. The PHQ-8 is an 8-item scale with total scores between 0 and 12. Higher scores indicate higher depression severity.	12 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ) scale	Validated, self-reported scale for the measurement of sleep quality. The LSEQ is a 10-item scale. Each item is scored 0 to 100. Higher scores indicate better sleep quality.	12 weeks
Short Form-20 (SF-20) scale	Validated, self-reported scale for the assessment of subjective quality of life. The SF-20 is a 20-item scale. Each item is scored 0-100. Higher scores indicate better subjective quality of life.	12 weeks
Digestion-associated Quality of Life Questionnaire (DQLQ)	Validated, self-reported scale for the measurement of digestion-associated quality of life outcomes. The DQLQ is a 9-item scale with total scores between 0 and 9. Each item is scored as a percentage 0-100, with 100 representing a score of 1. Higher scores indicate greater dissatisfaction with digestion-associated quality of life outcomes.	12 weeks
Gastrointestinal Symptom Rating Scale (GSRS)	Validated, self-reported scale for the assessment of gastrointestinal symptoms and how much discomfort they cause. The GSRS consists of 15 items scored between 1 and 7 each. Higher scores indicate more severe symptoms.	12 weeks
Digit Symbol Substitution Test (DSST)	A timed test that measures psychomotor performance and cognitive function. The test taker is given a key grid of numbers and matching symbols, and a list of numbers and empty boxes. The test taker matches the symbols to the numbers in the empty boxes within the allowed time (90 seconds). Participants will be scored according to the number of symbols they correctly correlate with a number.	12 weeks
Word Recall Test (WRT)	A timed memory assessment that asks the test taker to recall a list of words. The test administrator reads a list of 15 words, and the test taker is asked to immediately write down all the words they remember. After 15 minutes, the test taker is asked to write down the words again. Participants will be scored based on the number of words they recall immediately and after 15 minutes.	12 weeks
Functional movement test	Functional Movement Test (FMT) is an assessment used to evaluate an individual's movement patterns, mobility, stability, and overall functional fitness. It consists of several fundamental movement tests designed to identify weaknesses, imbalances, or limitations in a person's functional ability. During an FMT, a person is asked to perform movements such as directional neck movements, arm reaches, squats, push-ups, and balance on one leg. Each movement is scored based on form and control.	12 weeks
Gut microbiome test	Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type)	12 weeks
Total steps	Daily number of steps measured with fitness trackers.	12 weeks
Sleep score	A personalized score, ranging from 1 to 100, that reflects quality of sleep based on factors like time asleep, deep and REM sleep.	12 weeks
Body mass index (BMI)	A calculation of body fat based on height and weight	12 weeks
Body mass percentage (%)	An estimation of bone, fat, muscle, and water mass %	12 weeks
Blood pressure (mmHg)	The force of blood pushing against the walls of arteries.	12 weeks
Heart rate (BPM)	The number of heart beats per minute	12 weeks
Waist circumference (cm)	The circumference of the waist measured at the thinnest point of the waist	12 weeks
Insulin (uIU/mL)	Serum marker used to determine insulin levels	12 weeks
Sex hormone binding globulin (nmol/L)	Serum marker used to determine SHBG (Sex Hormone Binding Globulin) levels	12 weeks
Testosterone (ng/dL)	Serum marker used to determine testosterone levels	12 weeks
Thyroxine (T4) (ng/dL)	Serum marker used to determine thyroxine (T4) levels	12 weeks
Thyroglobulin antibody (IU/mL)	Serum marker used to determine thyroglobulin antibody levels	12 weeks
Thyroid peroxidase antibody (IU/mL)	Serum marker used to determine thyroid peroxidase antibody levels	12 weeks
Vitamin B12 (pg/mL)	Serum marker used to determine Vitamin B12 levels	12 weeks
Ferritin (ng/mL)	Serum marker used to determine ferritin levels	12 weeks
Gamma-glutamyl transferase (GGT)	Serum marker used to determine GGT levels	12 weeks
Transferritin saturation	Serum test used to determine UIBC, TIBC, Iron, Fe Saturation%	12 weeks
Total sleep (minutes)	Total number of minutes asleep, as measured by fitness tracker.	12 weeks
Light sleep (%)	The percentage of time asleep spent in light sleep, as measured by fitness tracker.	12 weeks
Deep sleep (%)	The percentage of time asleep spent in deep sleep, as measured by fitness tracker.	12 weeks
REM sleep (%)	The percentage of time asleep spent in deep sleep, as measured by fitness tracker.	12 weeks
Active minutes	Number of daily active minutes as measured by fitness tracker.	12 weeks
Sedentary minutes	Number of daily sedentary minutes as measured by fitness tracker.	12 weeks
Active calories burned	Number of daily active calories burned as measured by fitness tracker.	12 weeks
Total calories burned	Number of daily total calories burned as measured by fitness tracker.	12 weeks

Collaborators and Investigators

• Sponsor: dōTERRA International
• Investigators: Principal Investigator: Nicole Stevens, PhD, doTERRA International LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Probiotic; Omega 3; Gene expression; Essential oil; Copaiba; Greens powder
• Other Study ID Numbers: DO-125023-FWS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No