Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change in body weight
研究概览
简要总结
The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.
详细描述
The participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. This second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. The caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.
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
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 59 years old;
- •Body mass index equal or greater 25 kg/m²;
- •Agree to sign the informed consent.
排除标准
- •Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);
- •Thyroid diseases or medications for its treatment;
- •Medications known to affect total energy expenditure;
- •Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters;
- •Previous surgery for weight loss;
- •Pregnancy or breast-feeding;
- •Alcohol use (>2 doses/day).
结局指标
主要结局
Change in body weight
时间窗: Baseline and weeks 2, 4 and 8
Body weight will be assessed by mechanical scale
次要结局
- Change in resting energy expenditure(Baseline and weeks 2, 4 and 8)
- Change in self-reported diet composition(Baseline and weeks 2, 4 and 8)
- Change in self-reported intervention adherence(Baseline and weeks 2, 4 and 8)
- Change in self-reported depression(Baseline and weeks 2, 4 and 8)
- Change in self-reported anxiety(Baseline and weeks 2, 4 and 8)
- Change in self-reported stress(Baseline and weeks 2, 4 and 8)
- Change in body composition(Baseline and weeks 2, 4 and 8)
- Change in self-reported energy intake(Baseline and weeks 2, 4 and 8)
- Change in metabolic profile(Baseline and weeks 2, 4 and 8)
研究者
Adaliene Versiani M. Ferreira
PhD
Federal University of Minas Gerais