NCT02407548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

March 25, 2015

Last Update Submit

June 21, 2017

Conditions

Dyslipidemia

Keywords

cholesterol effluxdyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Effects of CoQ10 on lipid profile

    Tg, Tc, LDL, HDL, APOA1,APOB

    6 months

Secondary Outcomes (2)

  • Effects of CoQ10 on blood glucose and insulin

    6 mouth

  • Effects of CoQ10 on oxidative stress and inflammation

    6 mouth

Other Outcomes (2)

  • Effects of CoQ10 on FGF21

    6 month

  • Effects of CoQ10 on cholesterol efflux from macrophages

    6 month

Study Arms (3)

combined group

EXPERIMENTAL

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

CoQ10 group

EXPERIMENTAL

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

placebo group

OTHER

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

Interventions

coenzyme Q10 vitamin E softgelDIETARY_SUPPLEMENT

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

combined group
coenzyme Q10 softgelDIETARY_SUPPLEMENT

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

CoQ10 group
placebo softgelDIETARY_SUPPLEMENT

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

placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongshan Street community health service centre

Guangzhou, Guangdong, 510000, China

Location

Related Publications (2)

  • 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.

    PMID: 35241098DERIVED

  • 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.

    PMID: 29454678DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • ling wenhua, professor

    SUN YAY-SEN UNIVERSITY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 3, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations

CN(1)