Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-04 @ 3:49 AM
Study NCT ID:
NCT06666894
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Fasting Versus Diet to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of Non-alcoholic fatty liver using ultrasonography', 'timeFrame': 'at baseline at after two months', 'description': 'usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease'}], 'secondaryOutcomes': [{'measure': 'assessment of change of lab profile using laboratory investigations', 'timeFrame': 'at baseline at after two months', 'description': "The study focuses on lipid profiles, glucose and insulin profiles, IL-6, and C- reactive protein. Blood samples are collected from the antecubital vein at baseline and after 8 weeks, and analyzed using the same reagent lot. Fasting total cholesterol, HDL-C, LDL-C, and triglycerides are measured using an enzymatic colorimetric method. LDL-C fraction is calculated using Friedewald's formula. Laboratory investigation before and after the study is conducted."}, {'measure': 'assessment of change of body mass index', 'timeFrame': 'at baseline at after two months', 'description': 'Anthropometric baseline characteristics of subjects by In Body 170 Pre \\& post the study being performed (BMI)'}, {'measure': 'assessment of macronutrients distribution', 'timeFrame': 'at baseline at after two months', 'description': '• Dietary assessment for macronutrients distribution by dietary 24-hour recall Highlighted among dietary assessment methods of the current diet for their interest \\& validity. It is a prospective, open ended survey method collecting data about the foods \\& beverages consumed over a previously specified period of time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fasting, Intermittent', 'Diet', 'Hypertension', 'Metabolic Syndrome', 'Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.', 'detailedDescription': 'Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-alcoholic fatty liver patients diagnosed by radiological ultrasound\n* BMI \\>30\n* All patients are sedentary lifestyle with little or no exercise.\n* High lipid profile (total cholesterol \\> 200, LDL \\> 130, TAGs \\> 150) patients by laboratory investigation.\n* High fasting insulin level \\> 20mlU/mL \\& high fasting Glucose level \\>100, HbA1c \\> 5.7 \\& high HOMA- IR \\> 2.5 patients by Laboratory investigation.\n* High inflammatory markers (IL6) patients.\n* Age ranged from 30 to 40 years old.\n\nExclusion Criteria:\n\n* Alcoholic fatty liver patients.\n* Cirrhosis patients.\n* Diabetes patients.\n* Cognitive impaired patients.\n* History of epilepsy patients.\n* Cardiac pacemaker patients.\n* Anemic patients\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06666894', 'briefTitle': 'Intermittent Fasting Versus Diet to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intermittent Fasting Versus Dietary Approach to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients', 'orgStudyIdInfo': {'id': 'Aya-005258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent fasting group', 'description': 'intermittent fasting time-restricted feeding (TRF) subjects consumed 100 % of their energy needs in an 8 hours period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. schedule (8-hr daily eating period, The remaining 16 hours per 24-hour period made up the fasting period)', 'interventionNames': ['Other: Intermittent fasting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diet group', 'description': 'the dietary approach to stop hypertension (DASH) subjects consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. (12-hr eating period).', 'interventionNames': ['Other: Dietary approach to stop hypertension (DASH)']}], 'interventions': [{'name': 'Intermittent fasting', 'type': 'OTHER', 'description': 'subjects consumed 100 % of their energy needs in an 8-h period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. The remaining 16 h per 24-h period made up the fasting period. Subjects in the ND group consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. all patients will be subjected to 30 minutes mild aerobic exercise on treadmill.', 'armGroupLabels': ['Intermittent fasting group']}, {'name': 'Dietary approach to stop hypertension (DASH)', 'type': 'OTHER', 'description': "The USDA's 2015-2020 Dietary Guidelines for Americans recommend a healthy eating pattern, including a variety of vegetables, fruits, whole grains, fat-free dairy, protein, and oils. Limit saturated fats, trans fats, added sugars, and sodium to less than 10% daily calories, 10% saturated fat daily calories, and 2,300 mg sodium per day.", 'armGroupLabels': ['Diet group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'out-patient clinic, faculty of physical therapy, Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Aya Gamal Khattab Omer', 'investigatorAffiliation': 'Cairo University'}}}}