A Randomized Crossover-Controlled Trial Investigating the Epigenetic Impact of a Greens-Based Supplement in Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in DNA Methylation in Peripheral Blood Mononuclear Cells
研究概览
简要总结
The primary purpose of this study is to assess changes in epigenetic markers of aging and physiological parameters in overweight older adults consuming a mixed greens-based supplement over a 30-day period in a randomized crossover design.
详细描述
Investigators will recruit 20 overweight/obese but otherwise healthy participants aged 50-65. Participants will be randomized to consume the greens-based supplement each morning for the first 30 days or second 30 days of the study. Usual diet, physical activity, and sleep patterns will be encouraged and monitored during the duration of the study.
Phlebotomy will be conducted at baseline, 30-day crossover, and 60-day follow-up to assess DNA methylation in peripheral blood mononuclear cells. Visceral and total body fat, stool microbiome composition, and actigraphy will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women of any ethnicity (women must be postmenopausal)
- •Body Mass Index > 30 kg/m^2
- •Low habitual dark green leafy vegetable consumption
- •Willing to adhere to study protocol and measures
- •Willing to communicate via smartphone technology
- •Able to read, write and speak English
排除标准
- •Overt cardiometabolic diseases such heart attack, stroke, diabetes, insulin resistance and non-alcoholic fatty liver disease, etc.
- •Diagnosis of a transient ischemic attack in the 6 months prior to screening
- •Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- •Food allergies
研究组 & 干预措施
Delayed supplementation
Participants will consume greens-based supplement for 30 days after living their normal lives (free-living) for 30 days.
干预措施: Greens-based Supplement (Dietary Supplement)
Immediate supplementation
Participant will consume greens-based supplement for 30 days after which they will crossover into a free-living/non-supplementation setting for 30 days.
干预措施: Greens-based Supplement (Dietary Supplement)
结局指标
主要结局
Changes in DNA Methylation in Peripheral Blood Mononuclear Cells
时间窗: Change from day 0 (baseline) to day 30 post intervention supplementation.
Change from Baseline in Epigenetic Aging Profiles (i.e. DNA Methylation), after 30 day intervention. Participants will provide blood samples at their baseline study visit, which occurs before the start of the intervention, and at their visit at the end of the 30th of intervention supplementation.
次要结局
- Fasting serum triglycerides(Change from day 0 (baseline) to day 30 post intervention supplementation.)
- Fasting serum low-density lipoproteins (LDL)(Change from day 0 (baseline) to day 30 post intervention supplementation.)
- Fasting serum blood glucose(Change from day 0 (baseline) to day 30 post intervention supplementation.)
- Visceral fat percentage(Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study))
- Total body fat percentage(Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study))
- Stool microbiome composition(Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study))
- Breath Hydrogen (ppm)(Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study))
- Breath Methane (ppm)(Change from Day 0 (baseline), Day 30 (Crossover/Midpoint ), and Day 60 (end of study))
- Physical Quality of Life(Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60))
- Sleep and Physical Activity- accelerometry(Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60))
- Total caloric intake(Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60))
- Mental Quality of Life(Change from Baseline (day 0), Crossover/Midpoint (day 30), and End of study (day 60))
研究者
Andrew Fruge
Associate Professor
Auburn University