Wellness and Epigenetic Impact of a Natural Product Supplement System Combined With Lifestyle Modification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Gene expression
研究概览
简要总结
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:
- How does daily ingestion of dietary supplements affect gene expression and hsCRP and vitamin D levels measured in blood?
- How does daily ingestion of dietary supplements affect anthropometric measurements, sleep and physical activity, and gut microbiome composition?
- How does daily ingestion of dietary supplements affect cognitive and subjective health parameters?
- Do prescriptive lifestyle modifications affect the supplements' efficacy?
- Is there a difference in outcomes between participants who take all four study supplements and those who take three study supplements with a placebo?
- Is ingesting dietary supplements for 12 weeks safe, as measured by laboratory tests and adverse events?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Failure to meet all listed inclusion criteria
研究组 & 干预措施
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.
干预措施: Supplement system + copaiba softgels (Dietary Supplement)
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.
干预措施: Supplement system + placebo softgels (Dietary Supplement)
结局指标
主要结局
Gene expression
时间窗: 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)
时间窗: 12 weeks
Serum marker for Vitamin D levels
High sensitivity C-reactive protein (mg/L)
时间窗: 12 weeks
Serum marker for hsCRP levels
次要结局
- Body mass index (BMI)(12 weeks)
- Body mass percentage (%)(12 weeks)
- Albumin (g/dL)(12 weeks)
- Blood urea nitrogen (BUN) (mg/dL)(12 weeks)
- Creatinine (mg/dL)(12 weeks)
- Alkaline phosphatase (U/L)(12 weeks)
- Alanine transaminase (ALT) (U/L)(12 weeks)
- Aspartate aminotransferase (AST) (U/L)(12 weeks)
- Calcium (mg/dL)(12 weeks)
- Carbon Dioxide (mmol/L)(12 weeks)
- Chloride (mmol/L)(12 weeks)
- Potassium (mmol/L)(12 weeks)
- Sodium (mmol/L)(12 weeks)
- Total bilirubin (mg/dL)(12 weeks)
- Total protein (g/dL)(12 weeks)
- White blood cells (x10E3/uL)(12 weeks)
- Red blood cells (x10E6/uL)(12 weeks)
- Thyroid peroxidase antibody (IU/mL)(12 weeks)
- Vitamin B12 (pg/mL)(12 weeks)
- Hemoglobin (g/dL)(12 weeks)
- Hematocrit (%)(12 weeks)
- Mean corpuscular volume (fL)(12 weeks)
- Mean corpuscular hemoglobin concentration (g/dL)(12 weeks)
- Red cell distribution width (%)(12 weeks)
- Platelets (x10E3/uL)(12 weeks)
- Neutrophils (%)(12 weeks)
- Monocytes (%)(12 weeks)
- Eosinophils (%)(12 weeks)
- Basophils (%)(12 weeks)
- Neutrophils (Absolute) (x10E3/uL)(12 weeks)
- Lymphocytes (Absolute) (x10E3/uL)(12 weeks)
- Monocytes (Absolute) (x10E3/uL)(12 weeks)
- Eosinophils (Absolute) (x10E3/uL)(12 weeks)
- Basophils (Absolute) (x10E3/uL)(12 weeks)
- Immature granulocytes (%)(12 weeks)
- Immature granulocytes (Absolute) (x10E3/uL)(12 weeks)
- Adverse events(12 weeks)
- Generalized Anxiety Disorder-7 (GAD-7) scale(12 weeks)
- Patient Health Questionnaire (PHQ-8) scale(12 weeks)
- Leeds Sleep Evaluation Questionnaire (LSEQ) scale(12 weeks)
- Short Form-20 (SF-20) scale(12 weeks)
- Digestion-associated Quality of Life Questionnaire (DQLQ)(12 weeks)
- Gastrointestinal Symptom Rating Scale (GSRS)(12 weeks)
- Digit Symbol Substitution Test (DSST)(12 weeks)
- Word Recall Test (WRT)(12 weeks)
- Functional movement test(12 weeks)
- Gut microbiome test(12 weeks)
- Total steps(12 weeks)
- Sleep score(12 weeks)
- Blood pressure (mmHg)(12 weeks)
- Heart rate (BPM)(12 weeks)
- Waist circumference (cm)(12 weeks)
- Insulin (uIU/mL)(12 weeks)
- Sex hormone binding globulin (nmol/L)(12 weeks)
- Testosterone (ng/dL)(12 weeks)
- Thyroxine (T4) (ng/dL)(12 weeks)
- Thyroglobulin antibody (IU/mL)(12 weeks)
- Ferritin (ng/mL)(12 weeks)
- Gamma-glutamyl transferase (GGT)(12 weeks)
- Transferritin saturation(12 weeks)
- Total sleep (minutes)(12 weeks)
- Light sleep (%)(12 weeks)
- Deep sleep (%)(12 weeks)
- Total calories burned(12 weeks)
- REM sleep (%)(12 weeks)
- Active minutes(12 weeks)
- Sedentary minutes(12 weeks)
- Active calories burned(12 weeks)