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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia

Treatments: Dietary Supplement: placebo softgel; Dietary Supplement: coenzyme Q10 vitamin E softgel; Dietary Supplement: coenzyme Q10 softgel

Study type: Interventional

Funder types: Other

Identifiers

NCT02407548

SunYat-senU002

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

combined group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: coenzyme Q10 vitamin E softgel

CoQ10 group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: coenzyme Q10 softgel

placebo group

Other group

Description:

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.

Treatment:

Dietary Supplement: placebo softgel