Zhongshan Ketogenic Diet Study 1

Summary

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.

Conditions

• Platelet Function and Thrombus Formation

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Fudan University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-10

Primary Completion

2025-08-18

Completion

2025-08-20

Countries

• China

Study Locations