Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT04004403
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2019-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alternate Day Fasting, Exercise, and NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'varady@uic.edu', 'phone': '3129967897', 'title': 'Krista Varady', 'organization': 'University of Illinois Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'The definition of adverse event does not differ from that of of the definitions of clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hepatic Steatosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.25', 'groupId': 'OG000', 'lowerLimit': '-4.46', 'upperLimit': '-0.04'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '1.2'}, {'value': '-5.48', 'groupId': 'OG002', 'lowerLimit': '-7.77', 'upperLimit': '-3.18'}, {'value': '-0.17', 'groupId': 'OG003', 'lowerLimit': '-2.17', 'upperLimit': '1.83'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)', 'unitOfMeasure': 'liver fat percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.45', 'groupId': 'OG000', 'lowerLimit': '-4.93', 'upperLimit': '-3.97'}, {'value': '-1.79', 'groupId': 'OG001', 'lowerLimit': '-2.33', 'upperLimit': '-1.26'}, {'value': '-4.18', 'groupId': 'OG002', 'lowerLimit': '-4.65', 'upperLimit': '-3.71'}, {'value': '-0.52', 'groupId': 'OG003', 'lowerLimit': '-1.', 'upperLimit': '-0.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by digital scale', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.24', 'groupId': 'OG000', 'lowerLimit': '-26.12', 'upperLimit': '3.64'}, {'value': '-0.70', 'groupId': 'OG001', 'lowerLimit': '-5.03', 'upperLimit': '3.64'}, {'value': '-5.97', 'groupId': 'OG002', 'lowerLimit': '-10.66', 'upperLimit': '-1.28'}, {'value': '0.65', 'groupId': 'OG003', 'lowerLimit': '-1.9', 'upperLimit': '3.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)', 'unitOfMeasure': 'U/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.39', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '-.98'}, {'value': '.34', 'groupId': 'OG001', 'lowerLimit': '-4.71', 'upperLimit': '5.39'}, {'value': '-1.59', 'groupId': 'OG002', 'lowerLimit': '-5.98', 'upperLimit': '2.79'}, {'value': '-0.33', 'groupId': 'OG003', 'lowerLimit': '-4.51', 'upperLimit': '3.85'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)', 'unitOfMeasure': 'U/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.14', 'groupId': 'OG000', 'lowerLimit': '-11.64', 'upperLimit': '1.35'}, {'value': '-2.12', 'groupId': 'OG001', 'lowerLimit': '-9.75', 'upperLimit': '5.5'}, {'value': '-5.28', 'groupId': 'OG002', 'lowerLimit': '-11.76', 'upperLimit': '1.21'}, {'value': '.62', 'groupId': 'OG003', 'lowerLimit': '-5.67', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.41', 'groupId': 'OG000', 'lowerLimit': '-13.58', 'upperLimit': '-1.24'}, {'value': '-3.93', 'groupId': 'OG001', 'lowerLimit': '-8.87', 'upperLimit': '1.01'}, {'value': '-9.59', 'groupId': 'OG002', 'lowerLimit': '-15.16', 'upperLimit': '-4.02'}, {'value': '1.22', 'groupId': 'OG003', 'lowerLimit': '-2.48', 'upperLimit': '4.92'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)', 'unitOfMeasure': 'uIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-3.07', 'upperLimit': '-.54'}, {'value': '-1.25', 'groupId': 'OG001', 'lowerLimit': '-2.76', 'upperLimit': '.27'}, {'value': '-2.55', 'groupId': 'OG002', 'lowerLimit': '-4.03', 'upperLimit': '-1.08'}, {'value': '0.49', 'groupId': 'OG003', 'lowerLimit': '-0.83', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by Homeostatic model assessment of insulin resistance (HOMA-IR). The HOMA-IR value was calculated using the formula: \\[HOMA-IR = glucose (mg/dL) × insulin (mU/L)/405\\]. Interpretation of HOMA-IR Scores: \\< 1.0: Normal insulin sensitivity; 1.0-1.9: Mild insulin resistance; \\> 2.0: Moderate to severe insulin resistance.', 'unitOfMeasure': 'index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'OG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'OG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.12', 'groupId': 'OG000', 'lowerLimit': '-.24', 'upperLimit': '.01'}, {'value': '.02', 'groupId': 'OG001', 'lowerLimit': '-.13', 'upperLimit': '.16'}, {'value': '-0.08', 'groupId': 'OG002', 'lowerLimit': '-.2', 'upperLimit': '.05'}, {'value': '.04', 'groupId': 'OG003', 'lowerLimit': '-0.08', 'upperLimit': '.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults with obesity and NAFLD'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'FG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'FG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'FG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Alternate Day Fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".'}, {'id': 'BG001', 'title': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'BG002', 'title': 'Combination Alternate Day Fasting Plus Exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.\n\nAlternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".\n\nExercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.'}, {'id': 'BG003', 'title': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '16', 'groupId': 'BG000'}, {'value': '44', 'spread': '13', 'groupId': 'BG001'}, {'value': '44', 'spread': '13', 'groupId': 'BG002'}, {'value': '44', 'spread': '12', 'groupId': 'BG003'}, {'value': '44', 'spread': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Adults with obesity and non-alcoholic fatty liver disease'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-15', 'size': 776722, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-18T17:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2019-06-28', 'resultsFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-22', 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hepatic Steatosis', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by digital scale'}, {'measure': 'Change in Alanine Aminotransferase (ALT)', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)'}, {'measure': 'Change in Aspartate Aminotransferase (AST)', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)'}, {'measure': 'Change in Fasting Glucose', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)'}, {'measure': 'Change in Fasting Insulin', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)'}, {'measure': 'Change in Insulin Resistance', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by Homeostatic model assessment of insulin resistance (HOMA-IR). The HOMA-IR value was calculated using the formula: \\[HOMA-IR = glucose (mg/dL) × insulin (mU/L)/405\\]. Interpretation of HOMA-IR Scores: \\< 1.0: Normal insulin sensitivity; 1.0-1.9: Mild insulin resistance; \\> 2.0: Moderate to severe insulin resistance.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Change from week 1 to week 12', 'description': 'Measured by a commercial lab (Medstar, Inc)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes. Innovative lifestyle strategies to treat NAFLD are critically needed. The proposed research will demonstrate that alternate day fasting (ADF) combined with exercise is an effective non-pharmacological therapy to treat NAFLD.', 'detailedDescription': "Nonalcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver (not resulting from excessive alcohol consumption). Approximately 65% of obese individuals have NAFLD, and this condition is strongly related to the development of insulin resistance and type 2 diabetes. While certain pharmacological agents have been shown to reduce liver fat (i.e. thiazolidinediones), there is mounting concern regarding the safety and weight-gaining effects of these compounds. In light of this, recent research has focused on non-pharmacological lifestyle therapies to reduce hepatic steatosis, such as daily calorie restriction combined with aerobic exercise. Evidence from clinical trials suggest that this combination is an effective lifestyle therapy improve liver fat content and hepatic insulin sensitivity.\n\nMore recently, it's been shown that intermittent fasting may produce even greater improvements in hepatic steatosis and hepatic insulin sensitivity, when compared to conventional calorie restriction. For instance, intrahepatic lipid accumulation was lower and insulin sensitivity was higher in mice fasted every other day, when compared to mice who were energy restricted every day. Moreover, data from human trials show that adults with obesity experience greater decreases in insulin and insulin resistance with intermittent fasting versus daily restriction. These findings suggest that intermittent fasting may be a more effective diet therapy to reduce hepatic steatosis and improve insulin sensitivity, when compared to daily calorie restriction. Although these findings are very promising, these data still require confirmation by a randomized controlled clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Age between 18 to 65 years old\n* BMI between 30.0 and 59.9 kg/m2\n* NAFLD (hepatic steatosis ≥ 5% confirmed by MRI-PDFF)\n* Sedentary (\\<20 min, 2x/week of light activity at 3-4 metabolic equivalents (METs) for 3 mo prior to study)\n\nEXCLUSION CRITERIA:\n\n* Have chronic liver disease other than NAFLD (hepatitis B or C, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency)\n* Consume excessive amounts of alcohol women: 70 g of ethanol (5 alcoholic drinks per week) and men 140 g of ethanol (10 drinks per week) in the past 6 months)\n* Have a history of known cardiovascular, pulmonary or renal disease\n* Diagnosed T1DM or T2DM\n* Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \\> 4 kg)\n* Are claustrophobic or have implanted metallic/electrical devices (e.g. cardiac pacemaker, neuro-stimulator)\n* Are taking drugs that induce steatosis (e.g. corticosteroids, estrogens, methotrexate, Ca channel blockers)\n* Are taking drugs that benefit NAFLD (e.g. betaine, pioglitazone, rosiglitazone, metformin, or gemifibrozil)\n* Are taking drugs that influence study outcomes (weight loss medications)\n* Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)\n* Are pregnant, or trying to become pregnant\n* Are smokers"}, 'identificationModule': {'nctId': 'NCT04004403', 'briefTitle': 'Alternate Day Fasting, Exercise, and NAFLD', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Alternate Day Fasting Combined With Exercise for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': '2019-0300'}, 'secondaryIdInfos': [{'id': 'R01DK119783', 'link': 'https://reporter.nih.gov/quickSearch/R01DK119783', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alternate day fasting', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".', 'interventionNames': ['Other: Alternate day fasting']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Combination alternate day fasting plus exercise', 'description': 'These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.', 'interventionNames': ['Other: Alternate day fasting', 'Other: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.'}], 'interventions': [{'name': 'Alternate day fasting', 'type': 'OTHER', 'description': 'The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".', 'armGroupLabels': ['Alternate day fasting', 'Combination alternate day fasting plus exercise']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.', 'armGroupLabels': ['Combination alternate day fasting plus exercise', 'Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Krista Varady, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition', 'investigatorFullName': 'Krista Varady', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}