Determination of effects of Coenzyme Q10 or ubiquinol in human gene expression and related physiological readouts
| ISRCTN | ISRCTN26780329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26780329 |
| Secondary identifying numbers | A 121/07 |
- Submission date
- 18/06/2012
- Registration date
- 29/06/2012
- Last edited
- 20/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Studies on cells and mice indicate a role for Coenzyme Q10 in gene expression (the process by which genetic instructions are used to make proteins). The reduced form of Coenzyme Q10, ubiquinol, also acts as an antioxidant and regenerator of other antioxidants such as vitamin E. The aim of this study is to determine the effects of ubiquinol on gene expression.
Who can participate?
Healthy male volunteers aged between 21 and 48
What does the study involve?
All participants take ubiquinol daily in the form of three soft gel capsules with each meal for 14 days. Blood samples are collected after two weeks of supplementation and the effects of ubiquinol on gene expression are assessed.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement in their antioxidative potential and fat metabolism. No side effects are expected.
Where is the study run from?
University of Kiel (Germany)
When is the study starting and how long is it expected to run for?
January 2009 to March 2009
Who is funding the study?
Kaneka Corporation (Japan)
Who is the main contact?
Prof. Dr Frank Döring
fdoering@molprev.uni-kiel.de
Contact information
Scientific
University of Kiel
Department of Moleccular Prevention
Heinrich-Hecht-Platz 10
Kiel
24118
Germany
| Phone | +49 (0)431 8805657 |
|---|---|
| fdoering@molprev.uni-kiel.de |
Study information
| Study design | Proof of principle study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Ubiquinol supplementation in humans: a proof of principle study |
| Study objectives | Coenzyme Q10 alters gene expression of inflammatory genes via DNA methylation. |
| Ethics approval(s) | Ethics committee of the Medical Faculty of Kiel University, 13/03/2007, ref: A 121/07 |
| Health condition(s) or problem(s) studied | Ubiquinol supplementation study |
| Intervention | Ubiquinol supplementation, all participants got the same treatment: 150 mg Q10H2 daily in the form of three softgel capsules (50 mg) with each principal meal for 14 days. |
| Intervention type | Supplement |
| Primary outcome measure | Total blood collected after two weeks of supplementation 1. CoQ10 Analysis 2. Routine blood parameters |
| Secondary outcome measures | 1. DNA methylation patterns 2. mRNA expression in monocytes |
| Overall study start date | 01/01/2009 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 53 |
| Key inclusion criteria | 1. Age >17 years 2. Gender: Male 3. No history of gastrointestinal, hepatic, cardiovascular or renal diseases 4. A habit of non- or occasional smoking and maintenance of usual nutrition habits |
| Key exclusion criteria | 1. Age <17 years 2. Gender: Female 3. History of gastrointestinal, hepatic, cardiovascular or renal diseases, smoking, eating disorders |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
24118
Germany
Sponsor information
Industry
c/o Kazunori Hosoe
3-2-4, Nakanoshima, Kita-ku
Osaka
530-8288
Japan
"ROR" |
https://ror.org/038ckz871 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | Yes | No | |
| Results article | results | 21/07/2011 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No | |
| Results article | results | 04/07/2014 | Yes | No |
Editorial Notes
20/10/2017: Plain English summary added.
