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

Tian Zezhong

Status: Enrolling

Conditions: Cardiovascular Diseases; Metabolic Syndrome

Treatments: Dietary Supplement: placebo; Dietary Supplement: coenzyme Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT06506630

20240703

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

CoQ10 1R

Placebo Comparator group

Description:

take orally 600 mg placebo per day

Treatment:

Dietary Supplement: placebo

CoQ10 2R

Experimental group

Description:

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

Treatment:

Dietary Supplement: coenzyme Q10

CoQ10 3R

Experimental group

Description:

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

Treatment:

Dietary Supplement: coenzyme Q10