Platelet Function and Thrombus FormationNCT07117903
Zhongshan Ketogenic Diet Study 1
A study testing Normal diet + aspirin and Ketogenic diet + aspirin in people with Platelet Function and Thrombus Formation, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Function and Thrombus Formation
- What is being tested?
- Normal diet + aspirin and Ketogenic diet + aspirin
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants reside in Shanghai.
- Participants have completed Zhongshan Ketogenic Diet Study 1 in 2025.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital Fudan university
Shanghai, Shanghai Municipality, 200020
Peng Zhang, +86-17854278317, zhangpeng56562020@163.com
About this study
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.
Read the 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.
- Conditions
- Platelet Function and Thrombus Formation
- Being tested
- Normal diet + vehicle, Normal diet + aspirin, Ketogenic diet + vehicle, Ketogenic diet + aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal diet + vehicleDietary supplement
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.
Normal diet + aspirinDietary supplement
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.
Ketogenic diet + vehicleDietary supplement
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.
Ketogenic diet + aspirinDietary supplement
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation and ATP release
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.
Measured: Day 8
Secondary outcomes (1)
Thrombus formation
Thrombus formation will be evaluated by a microfluidic whole-blood perfusion assay.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion18 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Function and Thrombus FormationStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Qi, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117903
- Sponsor's protocol ID
- Y2024-146
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhongshan Ketogenic Diet Study 1
- ClinicalTrials.gov ID
- NCT07117903
- Acronym / sponsor ID
- Y2024-146
- Conditions
- Platelet Function and Thrombus Formation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants reside in Shanghai.
- Participants have completed Zhongshan Ketogenic Diet Study 1 in 2025.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal diet + vehicleParticipants 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 + aspirinParticipants 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 + vehicleThe 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 + aspirinThe 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. | Dietary supplement | – |
Primary outcome
Platelet aggregation and ATP release
Time frame: 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.
1 secondary outcome
Thrombus formation
Time frame: Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Platelet Function and Thrombus Formation
Not yet recruitingObservational study
Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Perioperative Bleeding, Coagulopathy During Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet + aspirin and Ketogenic diet + aspirin in people with Platelet Function and Thrombus Formation, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong Qi (+86-15000702247, 15000702247@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation and ATP release (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.