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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Metabolic Syndrome

• Registration Number: NCT06506630
• Lead Sponsor: Tian Zezhong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
platelet aggregation	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	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	baseline and week 24	using Elisa kits to detect PF4, β-TG, RANTES, TGF-β1 and soluble P-selectin (sP-selectin) levels
cardiorespiratory fitness	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 Usual Gait Speed to Week 24	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).
Change from Baseline in Handgrip Strength to Week 24	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 Muscle Mass to Week 24	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).

Secondary Outcome Measures

Name	Time	Method
Blood pressure	baseline and week 24	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.
Blood lipids profile	baseline and week 24	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).
Fasting blood sugar	baseline and week 24	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.

Trial Locations

Locations (1)

School of Public Health (Shenzhen), Sun Yat-sen University; 🇨🇳 Shenzhen, China