Zhongshan Ketogenic Diet 1: ketogenic diet effects on platelets and clotting

Zhongshan Ketogenic Diet Study 1

This test looks at whether a 7-day ketogenic diet changes how platelets work and whether aspirin can block any increase in clotting risk for eligible adults in Shanghai.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Fudan University (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07117903 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial compared a 7-day calorie‑restricted, very‑low‑carbohydrate ketogenic diet (5% carbohydrates, 30% protein, 65% fat, 600 kcal daily deficit) to participants' usual diet. One meal per day was provided to support adherence in the ketogenic group while controls kept their normal eating patterns. Blood was drawn at baseline and after 7 days to measure plasma ketones, and post-intervention samples were incubated ex vivo with aspirin or vehicle. Platelet function was measured by aggregation and ATP release assays and thrombus formation was assessed using a microfluidic whole-blood perfusion system.

Who should consider this trial

Good fit: Ideal participants are adults living in Shanghai without metabolic, cardiovascular, liver, kidney, or severe neuropsychiatric disorders who meet the study's eligibility and completed the prior Zhongshan ketogenic protocol.

Not a fit: People with diabetes, hypertension, cardiovascular disease, current antiplatelet drug use, pregnancy or lactation, major organ disease, recent surgery, or serious psychiatric conditions are excluded and unlikely to benefit from these results.

Why it matters

Potential benefit: If successful, the results could clarify whether short-term ketogenic diets increase clotting tendency and whether aspirin can prevent that, informing dietary and medication advice to reduce thrombotic risk.

How similar studies have performed: Preclinical data and some clinical evidence show ketogenic diets can alter platelet activity and aspirin reliably inhibits platelets, but randomized human data specifically on KD-induced hypercoagulability are limited.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan hospital Fudan university — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zhiyong Qi

Conditions: Platelet Function and Thrombus Formation