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临床试验/NCT01379911
NCT01379911已完成不适用

Developing and Validating a Method for Satiety Studies

University of Guelph1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Self-reported ratings of satiety

研究概览

简要总结

Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.

This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years
  • •BMI of 20.0-24.9 kg/m2
  • •Regular yogurt consumers (i.e. > 3 servings per week)

排除标准

  • •Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.
  • •History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition
  • •Vegans or vegetarians who exclude dairy products
  • •Milk allergies or any other food allergies
  • •Anyone with known anaphylactic allergic reactions, food or otherwise
  • •Dislike or unwillingness to consume study foods
  • •Gastrointestinal disease or disorders, including Celiac disease, lactose intolerance, irritable bowel syndrome, etc.
  • •BMI <20.0 or > 25.0 kg/m2
  • •Current participation in diet/weight-loss programs and/or changes of > 5 kg body weight within the past 6 months
  • •Unusual dietary patterns (i.e. routinely skipping breakfast or other meals)
  • •Unusual sleep patterns (i.e. shift workers)
  • •High habitual intake of caffeinated beverages or alcohol
  • •Restrained or disinhibited eaters, defined by the Three Factor Eating Questionnaire

研究组 & 干预措施

Yogurt with added inulin

Active Comparator

Yogurt with 6g of added inulin

干预措施: Yogurt (Other)

Regular yogurt

Placebo Comparator

Regular yogurt without added inulin

干预措施: Yogurt (Other)

结局指标

主要结局

Self-reported ratings of satiety

时间窗: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.

The study consists of two trial days (pre- and post home consumption) per study period, one for each of 2 yogurts. Each study visit involves a 4-hour stay at the HNRU. The pre-study visit will be followed by a 6-day yogurt self-administration period where participants will consume the assigned yogurt at breakfast. Thus, the acute satiety effects of the yogurts will be replicated in a controlled (laboratory) setting and evaluated over a 6-day period in an uncontrolled (home/lifestyle) environment.

次要结局

  • Food intake(One week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Tucker

Manager, HNRU

University of Guelph

研究点 (1)

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