Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 3:18 PM
Study NCT ID:
NCT07117903
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zhongshan Ketogenic Diet Study 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet aggregation and ATP release', 'timeFrame': 'Day 8', 'description': 'Platelet aggregation and ATP release were measured simultaneously using a lumi-aggregometer. Platelet aggregation was stimulated with collagen, thrombin, and ADP, while ATP release was induced by collagen and thrombin.'}], 'secondaryOutcomes': [{'measure': 'Thrombus formation', 'timeFrame': 'Day 8', 'description': 'Thrombus formation will be evaluated by a microfluidic whole-blood perfusion assay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Function and Thrombus Formation']}, 'descriptionModule': {'briefSummary': 'This dietary intervention study was designed to investigate the impact of a ketogenic diet on platelet function and and thrombus formation. Based on our preclinical observations, the study also aimed to discover whether aspirin could effectively counteract the ketogenic diet-induced enhancement of platelet function and attenuate the associated prothrombotic state.', 'detailedDescription': 'A randomized controlled trial was conducted to evaluate the impact of a ketogenic diet (KD) on platelet function and thrombus formation compared to a normal diet. Participants who met the specified inclusion and exclusion criteria were randomly assigned to either the KD group or the control group. The KD group followed a calorie-restricted, very-low-carbohydrate, high-fat diet for 7 days (5% carbohydrates, 30% protein, 65% fat, with a daily energy deficit of 600 kcal). To ensure compliance, one meal per day was provided as a commercial replacement. The normal diet group was instructed to maintain their original eating habits and rhythms. Whole blood was collected from the median cubital vein at baseline (pre-intervention) and after 7 days of the dietary intervention. Plasma ketone body levels were measured at both time points. To determine the effects of aspirin, the post-intervention whole blood was incubated ex vivo with either aspirin or a vehicle control. Platelet function was subsequently analyzed using platelet aggregation and ATP release assays, while thrombus formation was evaluated using a microfluidic whole-blood perfusion assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants reside in Shanghai.\n2. Participants have completed Zhongshan Ketogenic Diet Study 1 in 2025.\n\nExclusion Criteria:\n\n1. Pecent anti-platelet drug usage.\n2. Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases.\n3. Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication.\n4. Being or to be pregnant or lactating.\n5. Participants with bulimia nervosa, post-traumatic stress disorder , chronic anxiety and depression or other critical neuronal disorder or history of relevant medication.'}, 'identificationModule': {'nctId': 'NCT07117903', 'briefTitle': 'Zhongshan Ketogenic Diet Study 1', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Zhongshan Ketogenic Diet Study 1', 'orgStudyIdInfo': {'id': 'Y2024-146'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Normal diet + vehicle', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in the control group were instructed to maintain their usual diet for the duration of the study. While they were free to choose their food, they were required to provide a detailed dietary record. After diet intervention, whole blood will be drawn and incubated with vehicle drug.'}, {'name': 'Normal diet + aspirin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in the control group were instructed to maintain their usual diet for the duration of the study. While they were free to choose their food, they were required to provide a detailed dietary record. After diet intervention, whole blood will be drawn and incubated with aspirin.'}, {'name': 'Ketogenic diet + vehicle', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The calorie-restricted KD intervention consisted of a very-low-carbohydrate, high-fat diet (5% of calories from carbohydrates, 30% from protein, and 65% from fat, with an energy deficit of 600 kcal/day, 3 meals distributed over 24 h: breakfast, lunch, and dinner). This intervention was performed without schedule restrictions and supported by commercial replacement meals only for the first meal (100 kcal, 15 g of protein, 3 g of fat, of which 1 g was saturated fat, and 50 mg of docosahexaenoic acid, 2 g of carbohydrates, of which \\< 1 g was simple sugars). After diet intervention, whole blood will be drawn and incubated with vehicle drug.'}, {'name': 'Ketogenic diet + aspirin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The calorie-restricted KD intervention consisted of a very-low-carbohydrate, high-fat diet (5% of calories from carbohydrates, 30% from protein, and 65% from fat, with an energy deficit of 600 kcal/day, 3 meals distributed over 24 h: breakfast, lunch, and dinner). This intervention was performed without schedule restrictions and supported by commercial replacement meals only for the first meal (100 kcal, 15 g of protein, 3 g of fat, of which 1 g was saturated fat, and 50 mg of docosahexaenoic acid, 2 g of carbohydrates, of which \\< 1 g was simple sugars). After diet intervention, whole blood will be drawn and incubated with aspirin.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200020', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Zhang', 'role': 'CONTACT', 'email': 'zhangpeng56562020@163.com', 'phone': '+86-17854278317'}], 'facility': 'Zhongshan hospital Fudan university', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhiyong Qi', 'role': 'CONTACT', 'email': '15000702247@163.com', 'phone': '+86-15000702247'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Zhiyong Qi', 'investigatorAffiliation': 'Fudan University'}}}}