Effects of Coenzyme Q10 Supplement on Cardiovascular Risk Factors in Subjects at High Risk of Metabolic Syndrome

NCT ID: NCT06506630

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2024-12-30

Brief 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 muscle function.

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

CoQ10 1R

take orally 600 mg placebo per day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

300 mg capsule twice a day

CoQ10 2R

take orally 600 mg drug per day (contains 100mg coenzyme Q10)

Group Type: EXPERIMENTAL

coenzyme Q10

Intervention Type: DIETARY_SUPPLEMENT

300 mg capsule twice a day

CoQ10 3R

take orally 600 mg drug per day (contains 200mg coenzyme Q10)

Group Type: EXPERIMENTAL

coenzyme Q10

Intervention Type: DIETARY_SUPPLEMENT

300 mg capsule twice a day

Interventions

coenzyme Q10

300 mg capsule twice a day

Intervention Type: DIETARY_SUPPLEMENT

placebo

300 mg capsule twice a day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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:

1. Aged 30-90 years old;

2. Two or more of following are acceptable:

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1. Abdominal obesity (central obesity): waist circumference >=90 cm for men and >=80cm for women;

2. Hyperglycemia: fasting blood glucose ≥ 5.6mmol/L or taking hypoglycemic drugs;

3. Hypertension: systolic blood pressure >=130mmHg and (or) diastolic blood pressure >=85mmHg or taking blood pressure medications;

4. Fasting TG>=1.70mmol/L or taking antihyperlipidemic drug;

5. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tian Zezhong

OTHER

Sponsor Role: lead

Responsible Party

Tian Zezhong

Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

School of Public Health (Shenzhen), Sun Yat-sen University

Shenzhen, , China

Site Status: RECRUITING

Countries

China

Central Contacts

yan yang

Role: CONTACT

yangyan3@mail.sysu.edu.cn

+86 20 8733 0687

Facility Contacts

Yan Yang

Role: primary

yangyan3@mail.sysu.edu.cn

+86 20 8733 0687

Other Identifiers

20240703

Identifier Type: -

Identifier Source: org_study_id