Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:27 PM
Study NCT ID:
NCT07447505
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018753', 'term': 'Diet, Protein-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association Between Glucose and Appetite (Exploratory)', 'timeFrame': '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.', 'description': 'CGM Glucose Concentration and Subjective Appetite Ratings at Predefined Time Points'}], 'primaryOutcomes': [{'measure': 'Daytime Satiety During Fasting Hours', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Glycemic Profiles During Fasting (CGM)', 'timeFrame': '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.', 'description': 'Interstitial glucose levels assessed using continuous glucose monitoring (CGM) to evaluate glucose patterns and variability during fasting hours.'}, {'measure': 'Post-Meal CGM Glucose Response', 'timeFrame': '0-120 minutes after the pre-fast meal during each intervention condition.', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glycemic Response; Satiety', 'Fasting, Time Restricted', 'Dietary Intervention', 'Postprandial Glucose']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEach 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.\n\nDuring 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.\n\nDuring 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.\n\nSubjective 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).\n\nExploratory analyses will examine temporal associations between CGM-derived glucose levels and glucose trends and subjective appetite sensations across the study day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Willingness to comply with study procedures, including fasting and continuous glucose monitoring\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Diagnosed diabetes mellitus or known metabolic disease\n* History of cardiovascular, gastrointestinal, or endocrine disorders that may affect study outcomes\n* Use of medications known to affect glucose metabolism or appetite\n* Pregnancy or lactation\n* Known allergy or intolerance to any study meal components (oats, dairy, peanuts, nuts, cranberries)'}, 'identificationModule': {'nctId': 'NCT07447505', 'acronym': 'FAST-SAT', 'briefTitle': 'Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal University'}, 'officialTitle': 'Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study', 'orgStudyIdInfo': {'id': 'KFU-2026-ETHICS3958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Protein, High-Fiber Pre-Fast Meal', 'description': 'Participants consume a standardized high-protein, high-fiber pre-fast meal for two consecutive days.', 'interventionNames': ['Other: High-Protein, High-Fiber Meal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-Protein, Low-Fiber Pre-Fast Meal', 'description': 'Participants follow standardized written dietary instructions to consume a low-protein, low-fiber pre-fast meal for two consecutive days.', 'interventionNames': ['Other: Low-Protein, Low-Fiber Meal']}], 'interventions': [{'name': 'High-Protein, High-Fiber Meal', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['High-Protein, High-Fiber Pre-Fast Meal']}, {'name': 'Low-Protein, Low-Fiber Meal', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Low-Protein, Low-Fiber Pre-Fast Meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31982', 'city': 'Al-Ahsa', 'state': 'Eastern Province', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Wafa Alotaibi, PhD', 'role': 'CONTACT', 'email': 'Walotaibi@kfu.edu.sa', 'phone': '+966135897656'}], 'facility': 'King Faisal University'}], 'centralContacts': [{'name': 'Wafa Alotaibi', 'role': 'CONTACT', 'email': 'Walotaibi@kfu.edu.sa', 'phone': '+966500358622'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saudi Food and Drug Authority', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Wafa Alotaibi', 'investigatorAffiliation': 'King Faisal University'}}}}