Zhongshan Ketogenic Diet Study 1

Not Applicable

Recruiting

• Conditions: Platelet Function and Thrombus Formation

• Registration Number: NCT07117903
• Lead Sponsor: Fudan University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study Start: 2025-08-10
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2025-08-18
• Study Completion: 2025-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

1. Pecent anti-platelet drug usage.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Platelet aggregation and ATP release	Day 8	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.

Secondary Outcome Measures

Name	Time	Method
Thrombus formation	Day 8	Thrombus formation will be evaluated by a microfluidic whole-blood perfusion assay.

Trial Locations

Locations (1)

Zhongshan hospital Fudan university; 🇨🇳 Shanghai, Shanghai, China