Developing Methods for Completing Future Satiety Studies
Developing and Validating a Method for Satiety Studies
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Guelph、Ontario、加拿大、N1G2W1
- Human Nutraceutical Research Unit, University of Guelph
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Smokers
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Yogurt with added inulin
Yogurt with 6g of added inulin
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安慰剂比较：Regular yogurt
Regular yogurt without added inulin
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-reported ratings of satiety
大体时间：Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
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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.
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Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Food intake
大体时间：One week
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Study will include food and caloric intake over entire study day and for 6 days subsequent to initial study visit.
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One week
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合作者和调查者
调查人员
- 首席研究员：Amanda J Wright, Ph.D.、University of Guelph
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.