The Effects of Dietary Supplement of Coenzyme Q10（CoQ10） on Dyslipidemia (TEDSCD)

The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia

In previous study the investigators found that CoQ10 can improve cholesterol efflux from macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria electron transport chain. So the investigators hypothesize that CoQ10 may have some health promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: coenzyme Q10 vitamin E softgel; Dietary supplement: coenzyme Q10 softgel; Dietary supplement: placebo softgel

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Hongshan Street community health service centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subjects were considered to have dyslipidemia if they met 2 of the following 4 criteria:

  • fasting total cholesterol concentration>200 mg/dL,
  • fasting triglyceride concentration>150mg/dL,
  • fasting LDL-cholesterol concentrations>100 mg/dL, or
  • fasting HDL-cholesterol concentrations>40 mg/dL.

Exclusion Criteria:

• history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.
• use any antioxidant such as Vitamin E, vitamin C,Phytochemicals and coenzyme Q10 within two months before trial.
• pregnant or lactating women

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined group; each coenzyme Q10 vitamin E softgel contain CoQ 10 30mg + vitamin E 16mg; The subjects in this arm take 2 softgels after lunch and supper respectively per day. Total supplementation is 120mgCoQ10 and 64mg vitamin per day. The duration is 24 weeks.	Dietary supplement: coenzyme Q10 vitamin E softgel; 4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.
Experimental: CoQ10 group; each softgel contain CoQ 10 30mg; The subjects in this arm take 2 softgels after lunch and supper respectively per day. Total supplementation is 120mgCoQ10 per day. The duration is 24 weeks.	Dietary supplement: coenzyme Q10 softgel; 4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.
Other: placebo group; each softgel contain no vitamin E, no CoQ10; The subjects in this arm take 2 softgels after lunch and supper respectively per day. The duration is 24 weeks.	Dietary supplement: placebo softgel; 4 placebo softgels per day. Keep normal lift style unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of CoQ10 on lipid profile	Tg, Tc, LDL, HDL, APOA1,APOB	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of CoQ10 on blood glucose and insulin	reflect insulin sensibility	6 mouth
Effects of CoQ10 on oxidative stress and inflammation		6 mouth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of CoQ10 on FGF21	reflect glucose and lipid metabolism	6 month
Effects of CoQ10 on cholesterol efflux from macrophages		6 month

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: ling wenhua, professor, SUN YAY-SEN UNIVERSITY

Publications and helpful links

General Publications

• Zhang P, Chen K, He T, Guo H, Chen X. Coenzyme Q10 supplementation improves adipokine profile in dyslipidemic individuals: a randomized controlled trial. Nutr Metab (Lond). 2022 Mar 3;19(1):13. doi: 10.1186/s12986-022-00649-5.
• Zhang P, Yang C, Guo H, Wang J, Lin S, Li H, Yang Y, Ling W. Treatment of coenzyme Q10 for 24 weeks improves lipid and glycemic profile in dyslipidemic individuals. J Clin Lipidol. 2018 Mar-Apr;12(2):417-427.e5. doi: 10.1016/j.jacl.2017.12.006. Epub 2017 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: dyslipidemia; cholesterol efflux
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: SunYat-senU002