Clinical trial NCT06506630: Effects of Coenzyme Q10 Supplement on Cardiovascular Risk Factors in Subjects at High Risk of Metabolic Syndrome
Official title: Effects of Coenzyme Q10 Supplement on Cardiovascular Risk Factors in Subjects at High Risk of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Cardiovascular Diseases
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: platelet aggregation
timeFrame: baseline and week 24
measure: platelet acativation
timeFrame: baseline and week 24
measure: Platelet granule release
timeFrame: baseline and week 24
measure: cardiorespiratory fitness
timeFrame: baseline and week 24
measure: Change from Baseline in Muscle Mass to Week 24
timeFrame: baseline and week 24
measure: Change from Baseline in Handgrip Strength to Week 24
timeFrame: baseline and week 24
measure: Change from Baseline in Usual Gait Speed to Week 24
timeFrame: baseline and week 24
Secondary outcomes:
measure: Blood pressure
timeFrame: baseline and week 24
measure: Fasting blood sugar
timeFrame: baseline and week 24
measure: Blood lipids profile
timeFrame: baseline and week 24
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: School of Public Health (Shenzhen), Sun Yat-sen University
Study officials:
References: