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| Name | Class |
|---|---|
| Saudi Food and Drug Authority | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Protein, High-Fiber Pre-Fast Meal | Experimental | Participants consume a standardized high-protein, high-fiber pre-fast meal for two consecutive days. |
|
| Low-Protein, Low-Fiber Pre-Fast Meal | Active Comparator | Participants follow standardized written dietary instructions to consume a low-protein, low-fiber pre-fast meal for two consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Protein, High-Fiber Meal | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Profiles During Fasting (CGM) | Interstitial glucose levels assessed using continuous glucose monitoring (CGM) to evaluate glucose patterns and variability during fasting hours. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Glucose and Appetite (Exploratory) | CGM Glucose Concentration and Subjective Appetite Ratings at Predefined Time Points | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wafa Alotaibi | Contact | +966500358622 | Walotaibi@kfu.edu.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal University | Recruiting | Al-Ahsa | Eastern Province | 31982 | Saudi Arabia |
De-identified individual participant data (IPD) collected in this study will not be made publicly available. Data will be used for research purposes by the study investigators only
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| Low-Protein, Low-Fiber Meal | Other | 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. |
|
| 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). |
| 0-120 minutes after the pre-fast meal during each intervention condition. |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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