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

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 Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: coenzyme Q10

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Yang; Phone Number: +86 20 8733 0687; Email: yangyan3@mail.sysu.edu.cn

Study Locations

• China
  • Shenzhen, China, 518107
    • Recruiting
    • School of Public Health (Shenzhen), Sun Yat-sen University
    • Contact: Yan Yang; Phone Number: +86 20 8733 0687; Email: yangyan3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CoQ10 1R; take orally 600 mg placebo per day	Dietary supplement: placebo; 300 mg capsule twice a day
Experimental: CoQ10 2R; take orally 600 mg drug per day (contains 100mg coenzyme Q10)	Dietary supplement: coenzyme Q10; 300 mg capsule twice a day
Experimental: CoQ10 3R; take orally 600 mg drug per day (contains 200mg coenzyme Q10)	Dietary supplement: coenzyme Q10; 300 mg capsule twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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).	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).	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).	baseline and week 24
Change from Baseline in Usual Gait Speed to 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).	baseline and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	baseline and week 24

Collaborators and Investigators

• Sponsor: Tian Zezhong

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: 20240703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No