Healthy
Conditions
Keywords
Gene expression, Essential oil, Copaiba, Omega 3, Probiotic, Greens powder
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.
Interventions
DIETARY_SUPPLEMENTSupplement 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.
DIETARY_SUPPLEMENTSupplement 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.
Sponsors
dōTERRA International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression | 12 weeks | 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. |
| Vitamin D 25-hydroxy (ng/mL) | 12 weeks | Serum marker for Vitamin D levels |
| High sensitivity C-reactive protein (mg/L) | 12 weeks | Serum marker for hsCRP levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Albumin (g/dL) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Blood urea nitrogen (BUN) (mg/dL) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Creatinine (mg/dL) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Alkaline phosphatase (U/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Alanine transaminase (ALT) (U/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Aspartate aminotransferase (AST) (U/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Calcium (mg/dL) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Carbon Dioxide (mmol/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Chloride (mmol/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Potassium (mmol/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Sodium (mmol/L) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Total bilirubin (mg/dL) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| Total protein (g/dL) | 12 weeks | Item in comprehensive metabolic panel for safety assessment |
| White blood cells (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Red blood cells (x10E6/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Hemoglobin (g/dL) | 12 weeks | Item in complete blood count for safety assessment |
| Hematocrit (%) | 12 weeks | Item in complete blood count for safety assessment |
| Mean corpuscular volume (fL) | 12 weeks | Item in complete blood count for safety assessment |
| Mean corpuscular hemoglobin concentration (g/dL) | 12 weeks | Item in complete blood count for safety assessment |
| Red cell distribution width (%) | 12 weeks | Item in complete blood count for safety assessment |
| Platelets (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Neutrophils (%) | 12 weeks | Item in complete blood count for safety assessment |
| Monocytes (%) | 12 weeks | Item in complete blood count for safety assessment |
| Eosinophils (%) | 12 weeks | Item in complete blood count for safety assessment |
| Basophils (%) | 12 weeks | Item in complete blood count for safety assessment |
| Neutrophils (Absolute) (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Lymphocytes (Absolute) (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Monocytes (Absolute) (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Eosinophils (Absolute) (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Basophils (Absolute) (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Immature granulocytes (%) | 12 weeks | Item in complete blood count for safety assessment |
| Immature granulocytes (Absolute) (x10E3/uL) | 12 weeks | Item in complete blood count for safety assessment |
| Adverse events | 12 weeks | This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology/urine analyses. |
| Generalized Anxiety Disorder-7 (GAD-7) scale | 12 weeks | 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. |
| Patient Health Questionnaire (PHQ-8) scale | 12 weeks | 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. |
| Leeds Sleep Evaluation Questionnaire (LSEQ) scale | 12 weeks | 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. |
| Short Form-20 (SF-20) scale | 12 weeks | 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. |
| Digestion-associated Quality of Life Questionnaire (DQLQ) | 12 weeks | 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. |
| Gastrointestinal Symptom Rating Scale (GSRS) | 12 weeks | 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. |
| Digit Symbol Substitution Test (DSST) | 12 weeks | 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. |
| Word Recall Test (WRT) | 12 weeks | 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. |
| Functional movement test | 12 weeks | 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. |
| Gut microbiome test | 12 weeks | Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type) |
| Total steps | 12 weeks | Daily number of steps measured with fitness trackers. |
| Sleep score | 12 weeks | A personalized score, ranging from 1 to 100, that reflects quality of sleep based on factors like time asleep, deep and REM sleep. |
| Body mass index (BMI) | 12 weeks | A calculation of body fat based on height and weight |
| Body mass percentage (%) | 12 weeks | An estimation of bone, fat, muscle, and water mass % |
| Blood pressure (mmHg) | 12 weeks | The force of blood pushing against the walls of arteries. |
| Heart rate (BPM) | 12 weeks | The number of heart beats per minute |
| Waist circumference (cm) | 12 weeks | The circumference of the waist measured at the thinnest point of the waist |
| Insulin (uIU/mL) | 12 weeks | Serum marker used to determine insulin levels |
| Sex hormone binding globulin (nmol/L) | 12 weeks | Serum marker used to determine SHBG (Sex Hormone Binding Globulin) levels |
| Testosterone (ng/dL) | 12 weeks | Serum marker used to determine testosterone levels |
| Thyroxine (T4) (ng/dL) | 12 weeks | Serum marker used to determine thyroxine (T4) levels |
| Thyroglobulin antibody (IU/mL) | 12 weeks | Serum marker used to determine thyroglobulin antibody levels |
| Thyroid peroxidase antibody (IU/mL) | 12 weeks | Serum marker used to determine thyroid peroxidase antibody levels |
| Vitamin B12 (pg/mL) | 12 weeks | Serum marker used to determine Vitamin B12 levels |
| Ferritin (ng/mL) | 12 weeks | Serum marker used to determine ferritin levels |
| Gamma-glutamyl transferase (GGT) | 12 weeks | Serum marker used to determine GGT levels |
| Transferritin saturation | 12 weeks | Serum test used to determine UIBC, TIBC, Iron, Fe Saturation% |
| Total sleep (minutes) | 12 weeks | Total number of minutes asleep, as measured by fitness tracker. |
| Light sleep (%) | 12 weeks | The percentage of time asleep spent in light sleep, as measured by fitness tracker. |
| Deep sleep (%) | 12 weeks | The percentage of time asleep spent in deep sleep, as measured by fitness tracker. |
| REM sleep (%) | 12 weeks | The percentage of time asleep spent in deep sleep, as measured by fitness tracker. |
| Active minutes | 12 weeks | Number of daily active minutes as measured by fitness tracker. |
| Sedentary minutes | 12 weeks | Number of daily sedentary minutes as measured by fitness tracker. |
| Active calories burned | 12 weeks | Number of daily active calories burned as measured by fitness tracker. |
| Total calories burned | 12 weeks | Number of daily total calories burned as measured by fitness tracker. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNicole Stevens, PhD
doTERRA International LLC
Outcome results
None listed