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

Dyslipidemia Clinical Trial

— TEDSCD  

Official title:

The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407548
• Other study ID #: SunYat-senU002
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2015
• Last updated: June 21, 2017
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• coenzyme Q10 vitamin E softgel
4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.
• coenzyme Q10 softgel
4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.
• placebo softgel
4 placebo softgels per day. Keep normal lift style unchanged.

Locations

Country	Name	City	State
China	Hongshan Street community health service centre	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of CoQ10 on FGF21	reflect glucose and lipid metabolism	6 month
Other	Effects of CoQ10 on cholesterol efflux from macrophages		6 month
Primary	Effects of CoQ10 on lipid profile	Tg, Tc, LDL, HDL, APOA1,APOB	6 months
Secondary	Effects of CoQ10 on blood glucose and insulin	reflect insulin sensibility	6 mouth
Secondary	Effects of CoQ10 on oxidative stress and inflammation		6 mouth