Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Daytime Satiety During Fasting Hours
研究概览
简要总结
This randomized crossover study investigates the effect of consuming a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours in healthy adults. Participants will complete two dietary conditions in a randomized order: a standardized high-protein, high-fiber pre-fast meal and a low-protein, low-fiber pre-fast meal guided by dietary instructions. Each condition will be followed for two consecutive days and separated by a three-day washout period. Outcomes include subjective appetite sensations during fasting hours, glycemic profiles assessed using continuous glucose monitoring (CGM), and exploratory analyses examining the association between glucose dynamics and appetite sensations.
详细描述
This study is a randomized crossover interventional trial conducted in healthy adults to evaluate the effect of a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours.
Each participant will complete two study conditions in a randomized sequence: a high-protein, high-fiber pre-fast meal condition and a low-protein, low-fiber pre-fast meal condition. Each condition will be followed for two consecutive days and separated by a three-day washout period to minimize potential carryover effects.
During the high-protein, high-fiber condition, participants will consume a standardized pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g). Meals will be provided in pre-measured portions by the research team.
During the low-protein, low-fiber condition, participants will receive standardized written dietary instructions, including a list of foods to avoid, to guide consumption of a low-protein, low-fiber pre-fast meal. No calorie restriction will be applied in either study condition.
Subjective appetite sensations, including hunger, fullness, desire to eat, and prospective food consumption, will be assessed using visual analogue-type scales at predefined time points across the fasting day. Glycemic profiles will be continuously assessed using continuous glucose monitoring (CGM).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older
- •Willingness to comply with study procedures, including fasting and continuous glucose monitoring
- •Ability to provide informed consent
排除标准
- •Diagnosed diabetes mellitus or known metabolic disease
- •History of cardiovascular, gastrointestinal, or endocrine disorders that may affect study outcomes
- •Use of medications known to affect glucose metabolism or appetite
- •Pregnancy or lactation
- •Known allergy or intolerance to any study meal components (oats, dairy, peanuts, nuts, cranberries)
研究组 & 干预措施
High-Protein, High-Fiber Pre-Fast Meal
Participants consume a standardized high-protein, high-fiber pre-fast meal for two consecutive days.
干预措施: High-Protein, High-Fiber Meal (Other)
Low-Protein, Low-Fiber Pre-Fast Meal
Participants follow standardized written dietary instructions to consume a low-protein, low-fiber pre-fast meal for two consecutive days.
干预措施: Low-Protein, Low-Fiber Meal (Other)
结局指标
主要结局
Daytime Satiety During Fasting Hours
时间窗: Assessed at baseline prior to the pre-fast meal, 30 and 60 minutes post-meal, mid-afternoon (approximately 4:00 PM), and 30 minutes prior to breaking the fast during each intervention condition.
Subjective appetite sensations including hunger, fullness, desire to eat, and prospective food consumption assessed using a visual analogue-type scale with numeric anchors ranging from 0 to 10.
次要结局
- Glycemic Profiles During Fasting (CGM)(Assessed on Day 1 and Day 2 of each intervention period during the fasting window from completion of the pre-fast meal until breaking the fast.)
- Post-Meal CGM Glucose Response(0-120 minutes after the pre-fast meal during each intervention condition.)
研究者
Wafa Alotaibi
Assistant Professor
King Faisal University