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

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: coenzyme Q10 vitamin E softgel
* Dietary Supplement: coenzyme Q10 softgel
* Dietary Supplement: placebo softgel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined group<br>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<br>* 4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.<br>|
| Experimental: CoQ10 group<br>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<br>* 4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.<br>|
| Other: placebo group<br>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<br>* 4 placebo softgels per day. Keep normal lift style unchanged.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol efflux, dyslipidemia