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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement system + copaiba softgels | Dietary Supplement | The supplement system consists of:
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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Stevens, PhD | doTERRA International LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| doTERRA International | Pleasant Grove | Utah | 84062 | United States |
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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.
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| Supplement system + placebo softgels | Dietary Supplement | The supplement system consists of:
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. |
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| 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 |