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

NCT06506630 | Recruiting

• 1 other identifier: 20240703
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Blood pressure

  baseline and week 24

• Fasting blood sugar

  baseline and week 24

• Blood lipids profile

  baseline and week 24

Study Arms (3)

CoQ10 1R

PLACEBO COMPARATOR

take orally 600 mg placebo per day

Dietary Supplement: placebo

CoQ10 2R

EXPERIMENTAL

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

Dietary Supplement: coenzyme Q10

CoQ10 3R

EXPERIMENTAL

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

Dietary Supplement: coenzyme Q10

Interventions

coenzyme Q10 DIETARY_SUPPLEMENT

300 mg capsule twice a day

CoQ10 2R; CoQ10 3R

placebo DIETARY_SUPPLEMENT

300 mg capsule twice a day

CoQ10 1R

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Aged 30-90 years old;
• Two or more of following are acceptable:
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• Abdominal obesity (central obesity): waist circumference \>=90 cm for men and \>=80cm for women;
• Hyperglycemia: fasting blood glucose ≥ 5.6mmol/L or taking hypoglycemic drugs;
• Hypertension: systolic blood pressure \>=130mmHg and (or) diastolic blood pressure \>=85mmHg or taking blood pressure medications;
• Fasting TG\>=1.70mmol/L or taking antihyperlipidemic drug;
• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Tian Zezhong: lead

Study Sites (1)

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

Shenzhen, 518107, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

yan yang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 17, 2024
• Study Start: September 11, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)