About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years and older
Willingness to comply with study procedures, including fasting and continuous glucose monitoring
Ability to provide informed consent
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
High-Protein, High-Fiber Meal
Other interventionParticipants consume a standardized high-protein, high-fiber pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g) for two consecutive days.
Low-Protein, Low-Fiber Meal
Other interventionParticipants follow standardized written dietary instructions, including a list of foods to avoid, to consume a low-protein, low-fiber pre-fast meal for two consecutive days. No calorie restriction is applied.
Treatment groups
Trial outcomes
Primary outcomes
Daytime Satiety During Fasting Hours
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.
Secondary outcomes
Glycemic Profiles During Fasting (CGM)
Interstitial glucose levels assessed using continuous glucose monitoring (CGM) to evaluate glucose patterns and variability during fasting hours.
Post-Meal CGM Glucose Response
Continuous glucose monitoring-derived glucose response in the 0-120 minutes following consumption of the pre-fast meal, including peak glucose and incremental area under the curve (iAUC).
Other outcomes
Association Between Glucose and Appetite (Exploratory)
CGM Glucose Concentration and Subjective Appetite Ratings at Predefined Time Points
Locations
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Sponsors and contacts
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King Faisal University
Lead sponsor
Saudi Food and Drug Authority
Collaborator