Zhongshan Ketogenic Diet Study 1

Fudan University

Status

Enrolling

Conditions

Platelet Function and Thrombus Formation

Treatments

Dietary Supplement: Normal diet + aspirin

Dietary Supplement: Ketogenic diet + aspirin

Dietary Supplement: Normal diet + vehicle

Dietary Supplement: Ketogenic diet + vehicle

Study type

Interventional

Funder types

Other

Identifiers

NCT07117903

Y2024-146

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants reside in Shanghai.
Participants have completed Zhongshan Ketogenic Diet Study 1 in 2025.

Exclusion criteria

Pecent anti-platelet drug usage.
Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases.
Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication.
Being or to be pregnant or lactating.
Participants with bulimia nervosa, post-traumatic stress disorder , chronic anxiety and depression or other critical neuronal disorder or history of relevant medication.