A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Satiety
研究概览
简要总结
This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.
详细描述
The study is divided into 3 phases. Each phase involves eating one of 3 different breakfasts every day for 1 month. The order of the breakfast products is random. During each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. Gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (Asper site only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Males and females (not pregnant or lactating) aged 19 to 60 years.
- •Body mass index: 18.5-30 kg/m2.
排除标准
- •A change in medication (dose or type) or medical event requiring hospitalization within the past month.
- •Daily tobacco use.
- •Physical Activity Level >1.
- •Eat meals at irregular or unusual times.
- •Food allergy, aversion or unwillingness to eat study foods.
- •Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite or blood sugar.
- •Presence of a gastrointestinal disorder.
- •Taking drugs that affect gastric emptying.
- •Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.
研究组 & 干预措施
Control
breakfast food without viscous fibre
干预措施: breakfast (Other)
breakfast #1
breakfast food containing high viscosity fibre
干预措施: breakfast (Other)
breakfast #2
breakfast food containing low viscosity fibre
干预措施: breakfast (Other)
结局指标
主要结局
Satiety
时间窗: before the breakfast and every 30 minutes after breakfast for 4 hours
Total area under the curve (AUC) for hunger, fullness, desire to eat, and prospective consumption scales
Gastric emptying rate
时间窗: before the breakfast and every 15 minutes after breakfast for 4 hours
13C-Octanoic Acid will be incorporated into the breakfast food. Rate of gastric emptying will be determined by measuring 13C in breath samples.
次要结局
- Glucose and Insulin(before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.)
- Kilocalories(1 day)
研究者
Dr. Heather Blewett
Principal Investigator
St. Boniface Hospital