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临床试验/NCT02297880
NCT02297880已完成不适用

Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations

The Coca-Cola Company2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
2
主要终点
Subjective sensations: hunger, satiety and desire to eat

研究概览

简要总结

Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals.

详细描述

The study will be a monocentric randomized controlled open trial including two parallel groups to examine effects of LCS beverages as compared to water on daily intakes of energy and macronutrients. The effects of LCS beverages on hunger, satiety, desire to eat and on the selection of sweet or savory foods eating occasions will be assessed.

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index: Lower limit 18 kg/m²; Upper limit 28 kg/m²; weight stable within ± 3 kg in the last 6 months
  • Habitual energy intake within the 95% confident interval of the reference energy intake for the French population (as provided by the INCA 2 survey
  • Must not be a regular drinker of LCS beverages (less than once a week no more than every 15 days) and be willing to use LCS according to protocol
  • For female participants: not pregnant, not breast feeding, planning to become pregnant during the study or on contraception since at least 3 months (regular 28-day cycle)
  • Subject registered with the French Social Security.

排除标准

  • Currently diagnosed somatic pathology
  • On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months
  • Major psychiatric disorder, particularly eating disorders as defined by the Diagnostic and Statistical Manual od Mental Disorders-IV
  • Rejection of sweet foods or drinks as revealed by the diet history
  • Smoking subject planning to stop smoking in the next 3 months
  • Subjects suffering from food allergies or intolerance
  • Subject not capable of understanding the constraints of the study and who not agree to abide

结局指标

主要结局

Subjective sensations: hunger, satiety and desire to eat

时间窗: 9 weeks

Visual Analog Scales

次要结局

  • Energy and macronutrient intakes(9 weeks)
  • Anthropometric parameters(9 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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