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Completed

NCT Number: NCT02407548

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hongshan Street community health service centre

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coenzyme Q10 vitamin E softgel

Dietary Supplement

4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.

coenzyme Q10 softgel

Dietary Supplement

4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.

Placebo Softgel

Dietary Supplement

4 placebo softgels per day. Keep normal lift style unchanged.

Primary outcomes

  1. Effects of CoQ10 on lipid profile

    Time frame: 6 months

    Tg, Tc, LDL, HDL, APOA1,APOB

Secondary outcomes

  1. Effects of CoQ10 on blood glucose and insulin

    Time frame: 6 mouth

    reflect insulin sensibility

  2. Effects of CoQ10 on oxidative stress and inflammation

    Time frame: 6 mouth

Other outcomes

  1. Effects of CoQ10 on FGF21

    Time frame: 6 month

    reflect glucose and lipid metabolism

  2. Effects of CoQ10 on cholesterol efflux from macrophages

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia

Acronym: TEDSCD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2015
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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