Metabolic SyndromeNCT06506630
Effects of Coenzyme Q10 Supplement on Cardiovascular Risk Factors in Subjects at High Risk of Metabolic Syndrome
A study testing coenzyme Q10 in people with Metabolic Syndrome and Cardiovascular Diseases, run by Tian Zezhong at 1 site in China.
Trial summary
This study aims to evaluate the ameliorating effect of coenzyme Q10 supplementation on cardiovascular risk factors in high risk population for metabolic syndrome, including blood lipid metabolism, insulin resistance, blood pressure regulation, platelet function, endothelial function, cardiorespiratory fitness and… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Metabolic Syndrome, Cardiovascular Diseases
- What is being tested?
- coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic syndrome or high-risk groups with metabolic syndrome are defined as subjects with metabolic syndrome according to the International Diabetes Federation (IDF) Chinese Adult Criteria, and high-risk groups are defined as those who meet at least two MetS risk factors. The specific criteria are as follows:
- Aged 30-90 years old;
- Two or more of following are acceptable:
- <!-- -->
- Abdominal obesity (central obesity): waist circumference >=90 cm for men and >=80cm for women;
- Hyperglycemia: fasting blood glucose ≥ 5.6mmol/L or taking hypoglycemic drugs;
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- Hypertension: systolic blood pressure >=130mmHg and (or) diastolic blood pressure >=85mmHg or taking blood pressure medications;
- Fasting TG>=1.70mmol/L or taking antihyperlipidemic drug;
- Fasting HDL-C<1.04 mmol/L for men, <1.29 mmol/L for women or taking antihyperlipidemic drug; 3) Sign informed consent and insist on participating in the research.
Who cannot join
- 1) Take drugs/dietary supplements, such as aspirin, fish oil and etc., that affect platelet function in recently six months; 2) blood system disease or infection; 3) Blood pressure >=160/100mmHg; 4) Low platelet count (whole blood platelet<100 x 10^9/mL); 5) Abnormal hemoglobin (male <120g/L, female <110g/L); 6) Low hematocrit (male <40%, female <37%); 7) Prothrombin time (PT) is outside the normal reference range; 8) Pregnant women or nursing mothers; 9) Abnormal menstrual cycle, taking birth control pills or hormone replacement therapy; 10) Gastric ulcer, liver or kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Public Health (Shenzhen), Sun Yat-sen University
Shenzhen, 518107
Yan Yang, +86 20 8733 0687, yangyan3@mail.sysu.edu.cn
About this study
This study aims to evaluate the ameliorating effect of coenzyme Q10 supplementation on cardiovascular risk factors in high risk population for metabolic syndrome, including blood lipid metabolism, insulin resistance, blood pressure regulation, platelet function, endothelial function, cardiorespiratory fitness and muscle function.
- Conditions
- Metabolic Syndrome, Cardiovascular Diseases
- Being tested
- coenzyme Q10, placebo
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coenzyme Q10Dietary supplement
300 mg capsule twice a day
placeboDietary supplement
300 mg capsule twice a day
| Study group | Role | What they receive |
|---|---|---|
| CoQ10 1R | Placebo comparator | take orally 600 mg placebo per day Receives: Dietary Supplement: placebo |
| CoQ10 2R | Experimental | take orally 600 mg drug per day (contains 100mg coenzyme Q10) Receives: Dietary Supplement: coenzyme Q10 |
| CoQ10 3R | Experimental | take orally 600 mg drug per day (contains 200mg coenzyme Q10) Receives: Dietary Supplement: coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet aggregation
Fresh PRP prepared from subjects was stimulated by ADP at baseline and at 24 weeks. Platelet aggregation was evaluated on a Chronolog aggregometer (Chrono-Log Corp., PA, USA) in PRP (3.0 × 10^8 platelets/mL) at 37 °C, and the change in light transmission was monitored and recorded for at least 5 minutes.
Measured: baseline and week 24
platelet acativation
freshly isolated PRP was separately incubated with different fluorescent-labeled antibodies activated GPⅡbⅢa (FITC-conjugated mouse anti-human PAC-1) or P-selectin (FITC-conjugated mouse anti-human CD62P) at room temperature for 30 min. Platelets were initiated by adding 100 µmol/L adenosine diphosphate (ADP) at room temperature, followed by fixation with 1% paraformaldehyde (pH = 7.2) before analysis. All samples were analyzed via a calibrated CytoFLEX flow cytometer.
Measured: baseline and week 24
Platelet granule release
using Elisa kits to detect PF4, β-TG, RANTES, TGF-β1 and soluble P-selectin (sP-selectin) levels
Measured: baseline and week 24
cardiorespiratory fitness
using a comprehensive set of tests including spirometry for lung function, Incremental load test for exercise capacity, and a maximal oxygen uptake test (VO2 max) for aerobic fitness. Spirometry will quantify lung function by measuring forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Measured: baseline and week 24
Change from Baseline in Muscle Mass to Week 24
Muscle mass was measured by bioelectrical impedance analysis with the use of a body composition analyzer. Change = (Week 24 Muscle Mass - Baseline Muscle Mass).
Measured: baseline and week 24
Change from Baseline in Handgrip Strength to Week 24
Handgrip strength was measured by a hand dynamometer following a standardized procedure. Change = (Week 24 Handgrip Strength - Baseline Handgrip Strength).
Measured: baseline and week 24
Change from Baseline in Usual Gait Speed to Week 24
Usual gait speed was measured by the 6-metre walk test following a standardized procedure. Change = (Week 24 Usual Gait Speed - Baseline Usual Gait Speed).
Measured: baseline and week 24
Secondary outcomes (3)
Blood pressure
blood pressure will be assessed using a validated and calibrated sphygmomanometer. Blood pressure will be measured in millimeters of mercury (mmHg), with systolic and diastolic pressures recorded separately. Participants will be asked to rest for at least 5 minutes in a quiet environment before the measurement to ensure accuracy. The average of three consecutive readings, taken at 1-minute intervals, will be used to determine the participant's blood pressure.
Measured: baseline and week 24
Fasting blood sugar
Fasting blood glucose will be measured in milligrams per deciliter (mg/dL) using the standard hexokinase method. Participants are required to fast for at least 8 hours before blood sampling, with the exception of water. The test will be carried out in a laboratory setting using a calibrated automatic biochemical analyzer.
Measured: baseline and week 24
Blood lipids profile
including the assessment of six key components: total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A-I (Apo A-I) and B (Apo B). These measurements will be conducted using standard enzymatic assays in a clinical laboratory setting. Blood samples will be collected after an overnight fast of at least 8 to 12 hours. The results will be reported in milligrams per deciliter (mg/dL) for TC, TG, LDL-C, and HDL-CApo A-I and Apo B will be reported in grams per liter (g/L).
Measured: baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start11 Sep 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tian Zezhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tian Zezhong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506630
- Sponsor's protocol ID
- 20240703
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Coenzyme Q10 Supplement on Cardiovascular Risk Factors in Subjects at High Risk of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06506630
- Acronym / sponsor ID
- 20240703
- Conditions
- Metabolic Syndrome, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tian ZezhongUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Jul 2024 (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 study aims to evaluate the ameliorating effect of coenzyme Q10 supplementation on cardiovascular risk factors in high risk population for metabolic syndrome, including blood lipid metabolism, insulin resistance, blood pressure regulation, platelet function, endothelial function, cardiorespiratory fitness and muscle function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CoQ10 1R | Placebo comparator | Dietary Supplement: placebotake orally 600 mg placebo per day |
| CoQ10 2R | Experimental | Dietary Supplement: coenzyme Q10take orally 600 mg drug per day (contains 100mg coenzyme Q10) |
| CoQ10 3R | Experimental | Dietary Supplement: coenzyme Q10take orally 600 mg drug per day (contains 200mg coenzyme Q10) |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metabolic syndrome or high-risk groups with metabolic syndrome are defined as subjects with metabolic syndrome according to the International Diabetes Federation (IDF) Chinese Adult Criteria, and high-risk groups are defined as those who meet at least two MetS risk factors. The specific criteria are as follows:
- <!-- -->
Key exclusion criteria (1 listed)
- 1) Take drugs/dietary supplements, such as aspirin, fish oil and etc., that affect platelet function in recently six months; 2) blood system disease or infection; 3) Blood pressure >=160/100mmHg; 4) Low platelet count (whole blood platelet<100 x 10^9/mL); 5) Abnormal hemoglobin (male <120g/L, female <110g/L); 6) Low hematocrit (male <40%, female <37%); 7) Prothrombin time (PT) is outside the normal reference range; 8) Pregnant women or nursing mothers; 9) Abnormal menstrual cycle, taking birth control pills or hormone replacement therapy; 10) Gastric ulcer, liver or kidney dysfunction.
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 |
|---|---|---|
| coenzyme Q10300 mg capsule twice a day | Dietary supplement | CoQ10 2R, CoQ10 3R |
| placebo300 mg capsule twice a day | Dietary supplement | CoQ10 1R |
Primary outcome
platelet aggregation
Time frame: baseline and week 24
Fresh PRP prepared from subjects was stimulated by ADP at baseline and at 24 weeks. Platelet aggregation was evaluated on a Chronolog aggregometer (Chrono-Log Corp., PA, USA) in PRP (3.0 × 10^8 platelets/mL) at 37 °C, and the change in light transmission was monitored and recorded for at least 5 minutes.
platelet acativation
Time frame: baseline and week 24
freshly isolated PRP was separately incubated with different fluorescent-labeled antibodies activated GPⅡbⅢa (FITC-conjugated mouse anti-human PAC-1) or P-selectin (FITC-conjugated mouse anti-human CD62P) at room temperature for 30 min. Platelets were initiated by adding 100 µmol/L adenosine diphosphate (ADP) at room temperature, followed by fixation with 1% paraformaldehyde (pH = 7.2) before analysis. All samples were analyzed via a calibrated CytoFLEX flow cytometer.
Platelet granule release
Time frame: baseline and week 24
using Elisa kits to detect PF4, β-TG, RANTES, TGF-β1 and soluble P-selectin (sP-selectin) levels
cardiorespiratory fitness
Time frame: baseline and week 24
using a comprehensive set of tests including spirometry for lung function, Incremental load test for exercise capacity, and a maximal oxygen uptake test (VO2 max) for aerobic fitness. Spirometry will quantify lung function by measuring forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Change from Baseline in Muscle Mass to Week 24
Time frame: baseline and week 24
Muscle mass was measured by bioelectrical impedance analysis with the use of a body composition analyzer. Change = (Week 24 Muscle Mass - Baseline Muscle Mass).
Change from Baseline in Handgrip Strength to Week 24
Time frame: baseline and week 24
Handgrip strength was measured by a hand dynamometer following a standardized procedure. Change = (Week 24 Handgrip Strength - Baseline Handgrip Strength).
Change from Baseline in Usual Gait Speed to Week 24
Time frame: baseline and week 24
Usual gait speed was measured by the 6-metre walk test following a standardized procedure. Change = (Week 24 Usual Gait Speed - Baseline Usual Gait Speed).
3 secondary outcomes
Blood pressure
Time frame: baseline and week 24
Fasting blood sugar
Time frame: baseline and week 24
Blood lipids profile
Time frame: baseline and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coenzyme Q10 in people with Metabolic Syndrome and Cardiovascular Diseases, run by Tian Zezhong 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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yan yang (+86 20 8733 0687, yangyan3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet aggregation (time frame: baseline and week 24). The study lists 7 primary outcomes in all. 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 17 Jul 2024.