Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-08-10
2025-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Interventions
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Normal diet + vehicle
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.
Normal diet + aspirin
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.
Ketogenic diet + vehicle
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.
Ketogenic diet + aspirin
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.
Eligibility Criteria
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Inclusion Criteria
2. Participants have completed Zhongshan Ketogenic Diet Study 1 in 2025.
Exclusion Criteria
2. Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases.
3. Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication.
4. Being or to be pregnant or lactating.
5. Participants with bulimia nervosa, post-traumatic stress disorder , chronic anxiety and depression or other critical neuronal disorder or history of relevant medication.
18 Years
60 Years
ALL
Yes
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhiyong Qi
Dr.
Locations
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Zhongshan hospital Fudan university
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Y2024-146
Identifier Type: -
Identifier Source: org_study_id
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