The Effects of Diet and Lifestyle on Quality of Life and Methylation-related Biomarkers in Vivo.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
研究概览
简要总结
The maintenance of health and the progression of disease are associated with an individual's genetic make-up and environmental factors, including lifestyle choices (such as diet, exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and socioeconomic determinants. Environmental factors have been shown to influence, sometimes rapidly, epigenetic processes thereby influencing genetic expression. Regulation of the human genome by the epigenome is now regarded as a cornerstone, heritable, physiologic process, playing a key role in phenotypic expression of health and disease.
DNA methylation is a well-researched, primary epigenetic process. Aberrant DNA methylation resulting in hyper- or hypomethylated regions of the genome, generally results in inhibition or expression of certain genes and has been associated with the pathogenesis of numerous conditions, ranging from inflammation and accelerated aging, to cancer, autoimmunity, diabetes, heart disease, dementia, allergic disease, posttraumatic stress disease and others. Likewise, certain healthy diet and lifestyle habits have been demonstrated to favorably influence DNA methylation patterns.
Understanding that environmental factors can potently and sometimes rapidly, favorably or negatively influence epigenetic expression, a short-term diet and lifestyle intervention may significantly augment DNA methylation expression.
The purpose of this study is to evaluate a 9-week diet and lifestyle intervention on patient-reported quality of life, symptoms, and DNA and biochemical methylation-related biomarkers in healthy males ages 50-72.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •• Males, ages 50-72
- •Willing to adhere to 9 weeks of a dietary and lifestyle program including specific nutrition and exercise guidelines
- •Willing to avoid any over-the-counter medications, supplements or herbal products for the length of the study, except short-term use (<1 week) use at least 1 week before scheduled study visits
- •Willing to have blood drawn three times and abstain from food or beverage intake for 10-12 hours before blood draws
- •Willing to provide saliva samples
- •Willing to track food intake, sleep, stress management techniques, and exercise daily
- •Willing to drink a nutrient-enriched beverage and take a encapsulated probiotic daily
- •Willing and able to use electronic devices and connect to the internet
- •Able to speak, read and understand English
排除标准
- •• Currently taking any of the following prescription medications
- •Proton pump inhibitors: omeprazole (Prilosec, Prilosec OTC); aspirin and omeprazole (Yosprala); lansoprazole (Prevacid, Prevacid IV, Prevacid 24-Hour); ;dexlansoprazole (Dexilent, Dexilent Solutab); rabeprazole (Aciphex, Aciphex Sprinkle); pantoprazole (Protonix)
- •H2-blockers: nizatidine (Axid, Axid AR, Axid Pulvules); famotidine (Pepcid, Pepcid AC); cimetidine (Tagamet, Tagamet HB); ranitidine (Zantac)
- •These classes of medications are excluded due to direct (due to nutrient requirements for metabolism) and indirect (through impaired digestion and assimilation of nutrients).
- •Use of nutrition supplements or herbal products not prescribed by a licensed healthcare provider for a medical condition
- •Currently following a prescribed dietary/lifestyle program or initiate within the 30 days prior to baseline
- •Initiation of or changes to an exercise regimen within 30 days prior to baseline
- •Use of nicotine, marijuana or cannabinoids (including CBD products) or recreational drugs/substances (such as but not limited to cocaine, phencyclidine [PCP], and methamphetamine) current/within the last 30 days or use during the study
- •Have a diagnosis of cardiovascular disease, kidney disease, liver disease, diabetes, autoimmune disease, high blood pressure, or cancer (does not include basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix).
- •Have a diagnosis of an immunodeficiency condition, such as Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
- •Have a diagnosis of neurodegenerative conditions such as, amyotrophic lateral sclerosis (ALS), Parkinson's disease, Multiple Sclerosis, or Alzheimer's disease.
- •Excessive alcohol consumption (more than 4 drinks per day or 14 per week on average)
- •Known sensitivity, intolerance or allergy to ingredients in the study supplements or in the recommended dietary therapy
- •Currently receiving intravenous nutrient therapy
- •Currently participating in another interventional research study or participated in another interventional study within the last 3 weeks prior to baseline
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
时间窗: 8 weeks
PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety.
次要结局
- National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire(8 weeks)
- Measure Yourself Medical Outcome Profile (MYMOP)(8 weeks)