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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02407548

Collaborator

(none)

150

Enrollment

Location

Arms

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Dietary Supplement: coenzyme Q10 vitamin E softgel Dietary Supplement: coenzyme Q10 softgel Dietary Supplement: placebo softgel	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Effects of CoQ10 on lipid profile [6 months]
Tg, Tc, LDL, HDL, APOA1,APOB

Secondary Outcome Measures

Effects of CoQ10 on blood glucose and insulin [6 mouth]
reflect insulin sensibility
Effects of CoQ10 on oxidative stress and inflammation [6 mouth]

Other Outcome Measures

Effects of CoQ10 on FGF21 [6 month]
reflect glucose and lipid metabolism
Effects of CoQ10 on cholesterol efflux from macrophages [6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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