NCT05207488招募中不适用
Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in gastrointestinal microbiota composition
研究概览
简要总结
This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study is a double-blind, placebo-controlled study.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-45 kg/m2
- •Without physician diagnosed gastrointestinal or metabolic diseases
- •Sedentary (< 30 minutes of moderate or high intensity exercise per week OR < 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)
- •Fully vaccinated against COVID-19
排除标准
- •Fasting blood glucose >126 mg/dL
- •Blood pressure >160/100 mm Hg
- •Physician diagnosed metabolic or gastrointestinal diseases or constipation
- •Heart conditions that may pose risk during exercise
- •Taking oral hypoglycemic agents or insulin
- •Pregnant, breastfeeding or postmenopausal
- •Smoke or consume > 2 alcoholic beverages/day, abuse drugs
- •Have had > 5% weight change in the past month or > 10% change in the past year
- •Have had any form of bariatric surgery or gallbladder removal
- •Have taken antibiotics during the previous 3 months
- •Unable to consume the experimental fiber
结局指标
主要结局
Changes in gastrointestinal microbiota composition
时间窗: Baseline & 6-week mark
Determine the impact of daily consumption of prebiotic combined with regular exercise on the gastrointestinal microbiota compared to control by sequencing the V4 region of the 16S rRNA gene in fecal samples.
Changes in gastrointestinal microbial-derived metabolite concentrations
时间窗: Baseline & 6-week mark
Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control.
次要结局
- Changes in fasting insulin(Baseline & 6-week mark)
- Changes in body composition(Baseline & 6-week mark)
- Changes in fasting glucose(Baseline & 6-week mark)
- Changes in body fat distribution(Baseline & 6-week mark)
- Changes in cognition(Baseline & 6-week mark)
研究者
研究点 (2)
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