Zhongshan Ketogenic Diet 1: ketogenic diet effects on platelets and clotting
Official title: Zhongshan Ketogenic Diet Study 1
Run by Fudan University · NCT07117903 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 10, 2025 |
| Main results expected | August 18, 2025 |
| Study ends | August 20, 2025 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT07117903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Zhongshan hospital Fudan university
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Zhiyong Qi
- Email: 15000702247@163.com
- Phone: +86-15000702247
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.