Appetite Responses to Cereal Products: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for Desire to Eat 0-240 minutes
研究概览
简要总结
The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 18-70 years old
- •Habitual cereal consumers (at least several times per month)
- •Body mass index 18.5-24.9 kg/m2 (based on self-reported weight and height
- •Understand and willing to follow the study procedures
- •Willing to drink skim milk
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study
- •Willing to abstain from strenuous exercise and consuming alcoholic drinks 24 hours before the test day
- •Willing to provide Informed Consent to participate in the study
排除标准
- •Pregnant or lactating women, or women who are planning to become pregnant during the study
- •Known food allergies, sensitivities, or intolerance to any food or food ingredients
- •Participation in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
- •Taking medication(s) that affect appetite, metabolism or blood pressure
- •Presence of acute diseases or infection
- •Presence or history of chronic diseases
- •Diagnosed with an eating disorder
- •Restraint eaters as determined by score >4 from the Dutch Eating Behavior Questionnaire
- •Lost or gained 5 or more pounds in the past 3 months
- •On a weight loss diet or undergoing intermittent fasting
- •COVID-19 infection within the past 3 months
- •Subjects who do not eat cereal products
研究组 & 干预措施
Cereal Product 2
Ready to Eat Cereal Product 2 with 6 oz of skim milk
干预措施: Ready to Eat Cereal (Other)
Cereal Product 1
Ready to Eat Cereal Product 1 with 6 oz of skim milk
干预措施: Ready to Eat Cereal (Other)
Control
No intervention (i.e., no food provided)
结局指标
主要结局
Visual Analogue Scale for Desire to Eat 0-240 minutes
时间窗: 240 min
Visual Analogue Scale for "how strong is your desire to eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more desire to eat. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.
Visual Analogue Scale for Fullness 0-240 minutes
时间窗: 240 min
Visual Analogue Scale for "how full are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more fullness. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.
Visual Analogue Scale for Hunger 0-240 minutes
时间窗: 240 minutes
Visual Analogue Scale for "how hungry are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more hunger. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.
Visual Analogue Scale for Satisfaction 0-240 minutes
时间窗: 240 min
Visual Analogue Scale for "how satisfied are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satisfaction. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.
Visual Analogue Scale for Satiation 0-240 minutes
时间窗: 0-240 min
Visual Analogue Scale for "how satiated are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satiation. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.
Visual Analogue Scale for Prospective Consumption 0-240 minutes
时间窗: 240 min
Visual Analogue Scale for "how much do you think you can eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more prospective consumption. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.
次要结局
未报告次要终点