DyslipidemiaPhase 3TEDSCDNCT02407548
The Effects of Dietary Supplement of Coenzyme Q10（CoQ10） on Dyslipidemia
A Phase 3 study testing coenzyme Q10 vitamin E softgel and coenzyme Q10 softgel in people with Dyslipidemia, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- coenzyme Q10 vitamin E softgel and coenzyme Q10 softgel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Hongshan Street community health service centre
Guangzhou, Guangdong, 510000
About this study
Official title: The Effects of Dietary Supplement of Coenzyme Q10 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.
- Conditions
- Dyslipidemia
- Being tested
- coenzyme Q10 vitamin E softgel, coenzyme Q10 softgel, placebo softgel
- Keywords
- cholesterol efflux, dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coenzyme Q10 vitamin E softgelDietary supplement
4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.
coenzyme Q10 softgelDietary supplement
4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.
placebo softgelDietary supplement
4 placebo softgels per day. Keep normal lift style unchanged.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: placebo softgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of CoQ10 on lipid profile
Tg, Tc, LDL, HDL, APOA1,APOB
Measured: 6 months
Secondary outcomes (2)
Effects of CoQ10 on blood glucose and insulin
reflect insulin sensibility
Measured: 6 mouth
Effects of CoQ10 on oxidative stress and inflammation
Measured: 6 mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangpeiwen, Sun Yat-sen University
- Investigators
- ling wenhua, professor, Study director, SUN YAY-SEN UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407548
- Sponsor's protocol ID
- SunYat-senU002
- Acronym
- TEDSCD
- Status last verified
- Jun 2017
- First submitted
- 25 Mar 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35241098Zhang 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.
PubMed 29454678
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia
- ClinicalTrials.gov ID
- NCT02407548
- Acronym / sponsor ID
- TEDSCD / SunYat-senU002
- Conditions
- Dyslipidemia
- Keywords
- cholesterol efflux, dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined group | Experimental | Dietary Supplement: coenzyme Q10 vitamin E softgeleach 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. |
| CoQ10 group | Experimental | Dietary Supplement: coenzyme Q10 softgeleach 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. |
| placebo group | Other | Dietary Supplement: placebo softgeleach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects were considered to have dyslipidemia if they met 2 of the following 4 criteria:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coenzyme Q10 vitamin E softgel4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged. | Dietary supplement | combined group |
| coenzyme Q10 softgel4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged. | Dietary supplement | CoQ10 group |
| placebo softgel4 placebo softgels per day. Keep normal lift style unchanged. | Dietary supplement | placebo group |
Primary outcome
Effects of CoQ10 on lipid profile
Time frame: 6 months
Tg, Tc, LDL, HDL, APOA1,APOB
2 secondary outcomes
Effects of CoQ10 on blood glucose and insulin
Time frame: 6 mouth
Effects of CoQ10 on oxidative stress and inflammation
Time frame: 6 mouth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Derived from this study: PubMed 35241098Zhang 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.
- Derived from this study: PubMed 29454678Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ling wenhua, professor study director
SUN YAY-SEN UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing coenzyme Q10 vitamin E softgel and coenzyme Q10 softgel in people with Dyslipidemia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of CoQ10 on lipid profile (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.