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

Phase 3

Completed

• Conditions: Dyslipidemia
• Interventions: Dietary Supplement: coenzyme Q10 vitamin E softgel; Dietary Supplement: placebo softgel; Dietary Supplement: coenzyme Q10 softgel

• Registration Number: NCT02407548
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Study Start: 2015-07
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined group	coenzyme Q10 vitamin E softgel	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.
placebo group	placebo softgel	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.
CoQ10 group	coenzyme Q10 softgel	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.

Primary Outcome Measures

Name	Time	Method
Effects of CoQ10 on lipid profile	6 months	Tg, Tc, LDL, HDL, APOA1,APOB

Secondary Outcome Measures

Name	Time	Method
Effects of CoQ10 on oxidative stress and inflammation	6 mouth
Effects of CoQ10 on blood glucose and insulin	6 mouth	reflect insulin sensibility

Trial Locations

Locations (1)

Hongshan Street community health service centre; 🇨🇳 Guangzhou, Guangdong, China