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?
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
120
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.
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.
doTERRA International
Pleasant Grove, Utah, United States
RECRUITINGGene 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.
Time frame: 12 weeks
Vitamin D 25-hydroxy (ng/mL)
Serum marker for Vitamin D levels
Time frame: 12 weeks
High sensitivity C-reactive protein (mg/L)
Serum marker for hsCRP levels
Time frame: 12 weeks
Albumin (g/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Blood urea nitrogen (BUN) (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Creatinine (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Alkaline phosphatase (U/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Alanine transaminase (ALT) (U/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Aspartate aminotransferase (AST) (U/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Calcium (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Carbon Dioxide (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Chloride (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Potassium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Sodium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Total bilirubin (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
Total protein (g/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 12 weeks
White blood cells (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Red blood cells (x10E6/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Hemoglobin (g/dL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Hematocrit (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Mean corpuscular volume (fL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Mean corpuscular hemoglobin concentration (g/dL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Red cell distribution width (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Platelets (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Neutrophils (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Monocytes (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Eosinophils (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Basophils (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Neutrophils (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Lymphocytes (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Monocytes (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Eosinophils (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Basophils (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Immature granulocytes (%)
Item in complete blood count for safety assessment
Time frame: 12 weeks
Immature granulocytes (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Gut microbiome test
Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type)
Time frame: 12 weeks
Total steps
Daily number of steps measured with fitness trackers.
Time frame: 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.
Time frame: 12 weeks
Body mass index (BMI)
A calculation of body fat based on height and weight
Time frame: 12 weeks
Body mass percentage (%)
An estimation of bone, fat, muscle, and water mass %
Time frame: 12 weeks
Blood pressure (mmHg)
The force of blood pushing against the walls of arteries.
Time frame: 12 weeks
Heart rate (BPM)
The number of heart beats per minute
Time frame: 12 weeks
Waist circumference (cm)
The circumference of the waist measured at the thinnest point of the waist
Time frame: 12 weeks
Insulin (uIU/mL)
Serum marker used to determine insulin levels
Time frame: 12 weeks
Sex hormone binding globulin (nmol/L)
Serum marker used to determine SHBG (Sex Hormone Binding Globulin) levels
Time frame: 12 weeks
Testosterone (ng/dL)
Serum marker used to determine testosterone levels
Time frame: 12 weeks
Thyroxine (T4) (ng/dL)
Serum marker used to determine thyroxine (T4) levels
Time frame: 12 weeks
Thyroglobulin antibody (IU/mL)
Serum marker used to determine thyroglobulin antibody levels
Time frame: 12 weeks
Thyroid peroxidase antibody (IU/mL)
Serum marker used to determine thyroid peroxidase antibody levels
Time frame: 12 weeks
Vitamin B12 (pg/mL)
Serum marker used to determine Vitamin B12 levels
Time frame: 12 weeks
Ferritin (ng/mL)
Serum marker used to determine ferritin levels
Time frame: 12 weeks
Gamma-glutamyl transferase (GGT)
Serum marker used to determine GGT levels
Time frame: 12 weeks
Transferritin saturation
Serum test used to determine UIBC, TIBC, Iron, Fe Saturation%
Time frame: 12 weeks
Total sleep (minutes)
Total number of minutes asleep, as measured by fitness tracker.
Time frame: 12 weeks
Light sleep (%)
The percentage of time asleep spent in light sleep, as measured by fitness tracker.
Time frame: 12 weeks
Deep sleep (%)
The percentage of time asleep spent in deep sleep, as measured by fitness tracker.
Time frame: 12 weeks
REM sleep (%)
The percentage of time asleep spent in deep sleep, as measured by fitness tracker.
Time frame: 12 weeks
Active minutes
Number of daily active minutes as measured by fitness tracker.
Time frame: 12 weeks
Sedentary minutes
Number of daily sedentary minutes as measured by fitness tracker.
Time frame: 12 weeks
Active calories burned
Number of daily active calories burned as measured by fitness tracker.
Time frame: 12 weeks
Total calories burned
Number of daily total calories burned as measured by fitness tracker.
Time frame: 12 weeks
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