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临床试验/NCT03202069
NCT03202069已完成不适用

Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Body Composition

研究概览

简要总结

The purpose of this study is to determine the effects of daily protein intake patterns on body composition and eating behaviors during weight loss.

详细描述

The reinforcing value of food varies greatly among individuals, but is strongest for those who are overweight or obese. Reducing energy intake, which is necessary for overweight and obese individuals to achieve a healthier body weight, increases the reinforcing value of food - especially for energy-dense snack foods. Food is a powerful reinforcer and is associated with energy intake; making it a primary contributing factor to an individual's weight loss struggle. Developing a way to decrease or limit the increase in food reinforcement during energy deficits would have important clinical impact. High-protein diets are known to be efficacious for weight loss and recently have been shown to decrease stimulation of the reward areas of the brain that stimulate reward-driven eating behavior. Nonetheless, sustaining a high-protein diet can be difficult, especially for women. Consuming a modest amount of protein at each meal may be better tolerated. However, we do not know whether this pattern of protein intake can assist women in staying "on track" with weight loss goals. This study will help begin to elucidate the connections between the daily pattern of protein intake on diet adherence, alterations in food reinforcement, and favorable body composition changes during weight loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI 28-45 kg/m2

排除标准

  • unable or unwilling to consume animal products
  • unable or unwilling to attend treatment group meetings
  • had more than a 10% change in body weight in the 2 months prior to study start date
  • consuming a specialized diet
  • have a history of and eating or gastrointestinal disorder
  • currently or planning on becoming pregnant during the study timeline
  • lactating
  • have an uncontrolled metabolic illness/disease (fasting glucose >125 mg/dL)
  • have uncontrolled hypertension (>160/99 mm Hg)
  • have cancer or in short-term remission (less than 3 years)
  • have an infectious disease
  • suffer from alcohol or drug abuse
  • use tobacco and/or e-cigarette products on a regular basis
  • taking medications known to affect energy expenditure and appetite

结局指标

主要结局

Body Composition

时间窗: 8 and 16 weeks

Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.

Diet Adherence

时间窗: 16 weeks

Determine the effects of two patterns of daily protein intake on weight loss diet adherence and putative mediators (satisfaction, satiety, hunger, and reinforcing value of energy dense foods) of adherence.

次要结局

  • Change in bone turnover(8 and 16 weeks)
  • Barriers to weight control(1 hour)
  • Change in skeletal muscle protein breakdown(8 and 16 weeks)
  • Circulating carotenoid levels(8 and 16 weeks)
  • Relative reinforcing value (RRV) of food(8 and 16 weeks)
  • Plasma lipids(8 and 16 weeks)

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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