Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Gene Expression, Epigenetics and Nutritional Status in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gene expression
研究概览
简要总结
This is a global transcriptomics and epigenetic pilot study designed to identify changes in gene expression and DNA methylation patterns following the consumption of an MVM/phytochemical supplement in a small group of healthy subjects. We hypothesize that genome-wide transcriptional and epigenetic studies will elucidate the molecular mechanisms underlying the health benefits associated with MVM/phytochemical supplementation.
详细描述
There is considerable controversy regarding the benefit of widespread dietary supplement use, in particular widespread MVM use. The controversy persists because of a marked incongruity in nutrition research: on one hand, many studies indicate that MVM supplement consumption yields few - if any - demonstrable health benefits, yet on the other hand, numerous findings indicate most Americans do not consume the RDA of a variety of nutrients, particularly vitamins and minerals, and are becoming increasingly under-nourished. Nutrigenomics offers a unique opportunity to address this controversy, as it can identify subtle changes in gene expression and epigenetic signatures immediately following a nutritional intervention - changes which may be indicative of improved health status and which may otherwise remain undetectable through other clinical endpoints for a considerable period of time, even into future generations.
Hypothesis: The investigators hypothesize that MVM/phytochemical supplementation will result in transcriptional and epigenetic changes consistent with an enhancement in human health status. Moreover, the investigators hypothesize that MVM/phytochemical supplementation will alter markers of cardiovascular, antioxidant, nutritional as well as inflammatory status in a manner indicative of improved health.
Study Design:
This will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 4-week period. 50-60 healthy subjects will be recruited and, if eligible for the study, matched by age, sex and ethnicity and randomized in a 1:1 ratio to either of two interventions:
- Daily consumption of the control supplement (placebo)
- Daily consumption of the MVM/phytochemical supplement (treatment)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide a signed Informed Consent prior to entry in the study.
- •Are in generally good health.
- •Comprehensive Metabolic Panel results reported within normal reference ranges
- •Body Mass Index of 18.5 -
- •Systolic blood pressure of 90-130 mm Hg; diastolic blood pressure of 60-90 mm Hg.
- •Fasting blood glucose from 65-110 mg/dl.
- •Total cholesterol level of <240 mg/dl
- •LDL cholesterol of <130 mg/dl
- •Triglyceride level of <150 mg/dl.
- •Have good venous access.
- •Must be able to swallow tablets and pills
排除标准
- •Pregnant, trying to become pregnant, or breast feeding.
- •Chronic or acute use of prescription or OTC medications that may interfere with absorption of the test supplement.
- •Consumption of a multivitamin/mineral or other dietary supplement for more than 5 days within 30 days of the screening visit.
- •Gastrointestinal conditions that may affect consumption of the treatment or placebo tablets.
- •insulin-dependent and orally controlled diabetics
- •Scheduling difficulties or lack of transportation
- •Have participated as a subject in any other clinical study within 30 days of the screening visit
- •A history of alcohol or substance abuse within 2 years
- •Significant constipation or diarrhea
- •Allergies or intolerance to turmeric, curcumin or related products
- •Inability or difficulty swallowing tablets and pills
研究组 & 干预措施
MVM/phytochemical supplement
a multi-vitamin, multi-mineral, phytochemical supplement
干预措施: MVM/phytochemical supplement (Dietary Supplement)
Placebo
a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Gene expression
时间窗: 4 weeks
Gene expression measured by microarray
次要结局
- Cardiovascular Health(4 weeks)
- Nutritional status(4 weeks)
- Oxidative stress/Antioxidant Status(4 weeks)
- Epigenetics(4 weeks)
- Inflammation(4 weeks)