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

Tian Zezhong150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Metabolic Syndrome Cardiovascular Diseases

Interventions

coenzyme Q10DIETARY_SUPPLEMENT

300 mg capsule twice a day

placeboDIETARY_SUPPLEMENT

300 mg capsule twice a day

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 Years

Medical Language ↔ Plain English

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:  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.

Locations (1)

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

Shenzhen, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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).

Time frame: 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).

Time frame: 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).

Central Contacts

yan yang

CONTACT

+86 20 8733 0687 yangyan3@mail.sysu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: baseline and week 24