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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
coenzyme Q10 vitamin E softgel
coenzyme Q10 softgel
placebo softgel
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring cholesterol efflux, dyslipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hongshan Street community health service centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

combined group

CoQ10 group

placebo group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Effects of CoQ10 on lipid profile
Tg, Tc, LDL, HDL, APOA1,APOB

Secondary Outcome Measures

Effects of CoQ10 on blood glucose and insulin
reflect insulin sensibility
Effects of CoQ10 on oxidative stress and inflammation

Full Information

First Posted
March 25, 2015
Last Updated
June 21, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02407548
Brief Title
The Effects of Dietary Supplement of Coenzyme Q10（CoQ10） on Dyslipidemia
Acronym
TEDSCD
Official Title
The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
cholesterol efflux, dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combined group
Arm Type
Experimental
Arm Description
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.
Arm Title
CoQ10 group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
coenzyme Q10 vitamin E softgel
Intervention Description
4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.
Intervention Type
Dietary Supplement
Intervention Name(s)
coenzyme Q10 softgel
Intervention Description
4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo softgel
Intervention Description
4 placebo softgels per day. Keep normal lift style unchanged.
Primary Outcome Measure Information:
Title
Effects of CoQ10 on lipid profile
Description
Tg, Tc, LDL, HDL, APOA1,APOB
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effects of CoQ10 on blood glucose and insulin
Description
reflect insulin sensibility
Time Frame
6 mouth
Title
Effects of CoQ10 on oxidative stress and inflammation
Time Frame
6 mouth
Other Pre-specified Outcome Measures:
Title
Effects of CoQ10 on FGF21
Description
reflect glucose and lipid metabolism
Time Frame
6 month
Title
Effects of CoQ10 on cholesterol efflux from macrophages
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ling wenhua, professor
Organizational Affiliation
SUN YAY-SEN UNIVERSITY
Official's Role
Study Director
Facility Information:
Facility Name
Hongshan Street community health service centre
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35241098
Citation
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.
Results Reference
derived
PubMed Identifier
29454678
Citation
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.
Results Reference
derived

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

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