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临床试验/NCT01713114
NCT01713114Unknown不适用

A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety

The Hillshire Brands Company2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
试验地点
2
主要终点
Composite Area under the Curve - Visual Analog Scale

研究概览

简要总结

The primary objective of this study is to assess the acute effects of different meals on satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or meal skipping conditions.

详细描述

Satiety refers to feelings of fullness or lack of desire to eat following consumption of a food or meal. A number of dietary factors have been shown to influence satiety, including food volume, food weight, energy density, food palatability, and certain food ingredients. The nutritional composition of a meal appears to also play a significant role in an individual's feelings of satiety and ability to stay full until the next meal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • premenopausal Females
  • Ages 18-55
  • BMI between 18.5-29.9
  • Willing to maintain weight throughout study period

排除标准

  • Subject has a history of any surgical intervention for the treatment of obesity
  • Recent history or use of weight loss drugs, herbal supplements or on a dieting program or trying to loose weight
  • Gains or loses more than 6 pounds over the study period
  • Current or history of an eating disorder
  • Restrained eater
  • Excludes any foods or meals from their diet
  • History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, gastrointestinal, biliary, pancreatic or neurologic disorders
  • Signs of an infection
  • Heavy user of caffeine or alcohol
  • Unconventional sleep patterns (e.g. works 3rd shift)
  • Subject is pregnant or planning to become pregnant during the study period

结局指标

主要结局

Composite Area under the Curve - Visual Analog Scale

时间窗: Acute - up to 4 hrs

次要结局

  • Individual satiety measures - Area under the curve(4 hrs)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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