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

NCT ID: NCT02407548

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-04-30

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.

Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

coenzyme Q10 vitamin E softgel

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

coenzyme Q10 softgel

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type OTHER

placebo softgel

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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coenzyme Q10 vitamin E softgel

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

Intervention Type DIETARY_SUPPLEMENT

coenzyme Q10 softgel

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

Intervention Type DIETARY_SUPPLEMENT

placebo softgel

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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zhangpeiwen

PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ling wenhua, professor

Role: STUDY_DIRECTOR

SUN YAY-SEN UNIVERSITY

Locations

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Hongshan Street community health service centre

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Zhang P, Chen K, He T, Guo H, Chen X. Coenzyme Q10 supplementation improves adipokine profile in dyslipidemic individuals: a randomized controlled trial. Nutr Metab (Lond). 2022 Mar 3;19(1):13. doi: 10.1186/s12986-022-00649-5.

Reference Type DERIVED
PMID: 35241098 (View on PubMed)

Zhang P, Yang C, Guo H, Wang J, Lin S, Li H, Yang Y, Ling W. Treatment of coenzyme Q10 for 24 weeks improves lipid and glycemic profile in dyslipidemic individuals. J Clin Lipidol. 2018 Mar-Apr;12(2):417-427.e5. doi: 10.1016/j.jacl.2017.12.006. Epub 2017 Dec 21.

Reference Type DERIVED
PMID: 29454678 (View on PubMed)

Other Identifiers

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SunYat-senU002

Identifier Type: -

Identifier Source: org_study_id

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