King Faisal University
Al-Ahsa, Eastern Province, 31982, Saudi Arabia
Location status: Recruiting
NCT Number: NCT07447505
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Al-Ahsa, Eastern Province, 31982, Saudi Arabia
Location status: Recruiting
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).
Exploratory analyses will examine temporal associations between CGM-derived glucose levels and glucose trends and subjective appetite sensations across the study day.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants 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.
Participants 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.
Time frame: 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.
Time frame: 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.
Interstitial glucose levels assessed using continuous glucose monitoring (CGM) to evaluate glucose patterns and variability during fasting hours.
Time frame: 0-120 minutes after the pre-fast meal during each intervention condition.
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).
Time frame: Assessed on Day 1 and Day 2 of each intervention period at the predefined appetite assessment time points: baseline prior to the pre-fast meal, 30 minutes post-meal, 60 minutes post-meal, 4:00 PM, and 30 minutes prior to breaking the fast.
CGM Glucose Concentration and Subjective Appetite Ratings at Predefined Time Points
Contact information is provided by the study sponsor or research team.
King Faisal University
Other
Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study
Acronym: FAST-SAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02688283
Glycemic Response; Satiety
View Trial DetailsNCT06527703
Arterial Occlusive Diseases, Arteriosclerosis
San Ġiljan, Msida, Malta
View Trial DetailsNCT07705191
Blood Sugar (Glucose) Control, Postprandial Glucose
Tainan, Taiwan
View Trial DetailsNCT06884059
Behavior, Diabetes Mellitus
La Jolla, California, United States
View Trial Details