Clinical trial NCT06931977: Natural Product System and Lifestyle Modification
Official title: Wellness and Epigenetic Impact of a Natural Product Supplement System Combined With Lifestyle Modification
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Gene expression
Essential oil
Copaiba
Omega 3
Probiotic
Greens powder
Lead sponsor: dōTERRA International
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gene expression
timeFrame: 12 weeks
measure: Vitamin D 25-hydroxy (ng/mL)
timeFrame: 12 weeks
measure: High sensitivity C-reactive protein (mg/L)
timeFrame: 12 weeks
Secondary outcomes:
measure: Albumin (g/dL)
timeFrame: 12 weeks
measure: Blood urea nitrogen (BUN) (mg/dL)
timeFrame: 12 weeks
measure: Creatinine (mg/dL)
timeFrame: 12 weeks
measure: Alkaline phosphatase (U/L)
timeFrame: 12 weeks
measure: Alanine transaminase (ALT) (U/L)
timeFrame: 12 weeks
measure: Aspartate aminotransferase (AST) (U/L)
timeFrame: 12 weeks
measure: Calcium (mg/dL)
timeFrame: 12 weeks
measure: Carbon Dioxide (mmol/L)
timeFrame: 12 weeks
measure: Chloride (mmol/L)
timeFrame: 12 weeks
measure: Potassium (mmol/L)
timeFrame: 12 weeks
measure: Sodium (mmol/L)
timeFrame: 12 weeks
measure: Total bilirubin (mg/dL)
timeFrame: 12 weeks
measure: Total protein (g/dL)
timeFrame: 12 weeks
measure: White blood cells (x10E3/uL)
timeFrame: 12 weeks
measure: Red blood cells (x10E6/uL)
timeFrame: 12 weeks
measure: Hemoglobin (g/dL)
timeFrame: 12 weeks
measure: Hematocrit (%)
timeFrame: 12 weeks
measure: Mean corpuscular volume (fL)
timeFrame: 12 weeks
measure: Mean corpuscular hemoglobin concentration (g/dL)
timeFrame: 12 weeks
measure: Red cell distribution width (%)
timeFrame: 12 weeks
measure: Platelets (x10E3/uL)
timeFrame: 12 weeks
measure: Neutrophils (%)
timeFrame: 12 weeks
measure: Monocytes (%)
timeFrame: 12 weeks
measure: Eosinophils (%)
timeFrame: 12 weeks
measure: Basophils (%)
timeFrame: 12 weeks
measure: Neutrophils (Absolute) (x10E3/uL)
timeFrame: 12 weeks
measure: Lymphocytes (Absolute) (x10E3/uL)
timeFrame: 12 weeks
measure: Monocytes (Absolute) (x10E3/uL)
timeFrame: 12 weeks
measure: Eosinophils (Absolute) (x10E3/uL)
timeFrame: 12 weeks
measure: Basophils (Absolute) (x10E3/uL)
timeFrame: 12 weeks
measure: Immature granulocytes (%)
timeFrame: 12 weeks
measure: Immature granulocytes (Absolute) (x10E3/uL)
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7) scale
timeFrame: 12 weeks
measure: Patient Health Questionnaire (PHQ-8) scale
timeFrame: 12 weeks
measure: Leeds Sleep Evaluation Questionnaire (LSEQ) scale
timeFrame: 12 weeks
measure: Short Form-20 (SF-20) scale
timeFrame: 12 weeks
measure: Digestion-associated Quality of Life Questionnaire (DQLQ)
timeFrame: 12 weeks
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 12 weeks
measure: Digit Symbol Substitution Test (DSST)
timeFrame: 12 weeks
measure: Word Recall Test (WRT)
timeFrame: 12 weeks
measure: Functional movement test
timeFrame: 12 weeks
measure: Gut microbiome test
timeFrame: 12 weeks
measure: Total steps
timeFrame: 12 weeks
measure: Sleep score
timeFrame: 12 weeks
measure: Body mass index (BMI)
timeFrame: 12 weeks
measure: Body mass percentage (%)
timeFrame: 12 weeks
measure: Blood pressure (mmHg)
timeFrame: 12 weeks
measure: Heart rate (BPM)
timeFrame: 12 weeks
measure: Waist circumference (cm)
timeFrame: 12 weeks
measure: Insulin (uIU/mL)
timeFrame: 12 weeks
measure: Sex hormone binding globulin (nmol/L)
timeFrame: 12 weeks
measure: Testosterone (ng/dL)
timeFrame: 12 weeks
measure: Thyroxine (T4) (ng/dL)
timeFrame: 12 weeks
measure: Thyroglobulin antibody (IU/mL)
timeFrame: 12 weeks
measure: Thyroid peroxidase antibody (IU/mL)
timeFrame: 12 weeks
measure: Vitamin B12 (pg/mL)
timeFrame: 12 weeks
measure: Ferritin (ng/mL)
timeFrame: 12 weeks
measure: Gamma-glutamyl transferase (GGT)
timeFrame: 12 weeks
measure: Transferritin saturation
timeFrame: 12 weeks
measure: Total sleep (minutes)
timeFrame: 12 weeks
measure: Light sleep (%)
timeFrame: 12 weeks
measure: Deep sleep (%)
timeFrame: 12 weeks
measure: REM sleep (%)
timeFrame: 12 weeks
measure: Active minutes
timeFrame: 12 weeks
measure: Sedentary minutes
timeFrame: 12 weeks
measure: Active calories burned
timeFrame: 12 weeks
measure: Total calories burned
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pleasant Grove
country: United States
facility: doTERRA International
state: Utah
Study officials:
affiliation: doTERRA International LLC
name: Nicole Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: