The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Effects of CoQ10 on lipid profile
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: coenzyme Q10 vitamin E softgel (Dietary Supplement)
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.
Intervention: coenzyme Q10 softgel (Dietary Supplement)
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.
Intervention: placebo softgel (Dietary Supplement)
Outcomes
Primary Outcomes
Effects of CoQ10 on lipid profile
Time Frame: 6 months
Tg, Tc, LDL, HDL, APOA1,APOB
Secondary Outcomes
- Effects of CoQ10 on blood glucose and insulin(6 mouth)
- Effects of CoQ10 on oxidative stress and inflammation(6 mouth)
Investigators
zhangpeiwen
PhD candidate
Sun Yat-sen University