Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Participants are randomly assigned to the TRE or the non-fasting control group. The TRE group will consume calorie containing food and drink only over an 8 hour period and rest of the 16 hour would be fasting. Adherence to TRE and calorie intake are the primary outcomes. Motivators, facilitators and barriers to TRE, hunger and cravings levels, weight bias internalization, body composition (weight, body fat%, fat mass and muscle mass) , Healthy Eating Index (HEI) to assess diet quality, skin carotenoid levels, disordered eating risk, sleep quality, and perceptions of health and well-being are secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 to 65 years
- •Owns a smartphone
- •Apparently healthy
- •BMI ( more than or equal to 25 kg/m2 ) and high body fat percent (BF%) (≥25% and ≥35% for males and females, respectively)
- •Sedentary lifestyle (less than 150 minutes of self-reported moderate to vigorous activity per week)
- •Self-reported eating interval of ≥12 h per day
排除标准
- •Diagnosed diabetes mellitus (type I or II), coronary heart disease, heart failure, hypertension, hyperlipidemia, stroke, chronic lung diseases, liver or kidney disease, adrenal diseases, musculoskeletal disorders, uncontrolled thyroid disease (dose changes within the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness).
- •Currently taking any medication that is meant for, or has a known effect on, appetite
- •On anabolic steroid or hormone replacement therapy
- •Participation in an exercise/nutrition/ weight-loss program within the last 6 months
- •Any history of surgical intervention for weight management
- •Having a ≥5% body weight change during the last 3 months
- •Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation
- •missing limbs, have a pacemaker or metal implants,
- •eating disorders or EAT-26 score >20
- •Alcohol or drug addiction
- •Current smoker
- •Works night shifts
- •Unable to commit to a 9-week study
- •Not willing to follow study protocol and any other contraindications.
- •Currently following any of the following restrictive diets - Keto/low carbohydrate/ Vegan/ Vegetarian/ Intermittent fasting/ Paleo/ Calorie restriction/ Any other restrictive diet
- •Participating in another study
结局指标
主要结局
Adherence
时间窗: 8 weeks
Percent of days during the 8-week trial when TRE was adhered to as recommended. This will be self-reported daily.
Total calorie intake
时间窗: During baseline week and week 8 of the intervention
Pre and post intervention measurements of calorie intake based on three 24-hour food recall surveys using the NDSR software.
次要结局
- Body weight (kg)(At baseline and at the end of 8 weeks of intervention)
- 24-hour physical activity energy expenditure (PAEE)(During baseline week and week 8 of the intervention)
- Body fat percentage (%)(At baseline and at the end of 8 weeks of intervention)
- Fat-free mass (kg)(At baseline and at the end of 8 weeks of intervention)
- Fat mass (kg)(At baseline and at the end of 8 weeks of intervention)
- Hunger and satiety(During baseline week and week 8 of the intervention)
- Sleep quality(One time during the baseline week and week 8 of the intervention)
- Diet Quality(During baseline week and week 8 of the intervention)
- Perceptions of health and well-being(At baseline and at the end of 8 weeks of intervention)
- Weight Bias Internalization(At baseline and at the end of 8 weeks of intervention)
- Disordered eating risk(At baseline and at the end of 8 weeks of intervention)
- Eating Behavior(At baseline and at the end of 8 weeks of intervention)
- Skin carotenoid(At baseline and at the end of 8 weeks of intervention)
- Motivators, barriers, and facilitators for following time restricted eating(At end of 2nd week and during the 8th week of intervention.)
研究者
Nadeeja Wijayatunga
Assistant Professor
University of Mississippi, Oxford