Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resides in Northwest Arkansas
- •Age 25-50 years
- •BMI > 25
- •All ethnicities
- •Female and male
排除标准
- •Food allergies
- •Pregnant or breastfeeding
- •Dietary restrictions (e.g. vegetarian, vegan, etc.)
- •Trying to lose weight in last 3 months
- •Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)
- •Prescription medications related to heart disease or type 2 diabetes
- •Fear of needles
- •Smoker or vaping
- •Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes
- •Consumes >4 alcoholic beverages per week
结局指标
主要结局
Body composition
时间窗: Change is being assessed at baseline and final day (day 120) of the intervention.
Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.
次要结局
- Grit(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Amino acids and metabolites(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Whole body protein turnover(Change is being assessed at baseline and final day (day 120) of the intervention.)
- Muscle mass(Change is being assessed at baseline and final day (day 120) of the intervention.)
- Body weight(Change is being assessed at baseline, 4, 8, and 12 weeks.)
- Sleep(Change is being assessed at baseline and 12 weeks)
- Sleep Quality(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Self-reported physical activity(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Mood(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Hand grip(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Dietary intake(Change is being assessed at baseline, 4, 8, and 12 weeks)
- Fasting glucose(Change is being assessed at baseline, 4, 8, and 12 weeks)
研究者
Jamie Baum
Associate Professor
University of Arkansas, Fayetteville