Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Frank Döring
ORCID ID
Contact details
University of Kiel
Department of Moleccular Prevention
Heinrich-Hecht-Platz 10
Kiel
24118
Germany
+49 (0)431 8805657
fdoering@molprev.uni-kiel.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A 121/07
Study information
Scientific title
Ubiquinol supplementation in humans: a proof of principle study
Acronym
Study hypothesis
Coenzyme Q10 alters gene expression of inflammatory genes via DNA methylation.
Ethics approval
Ethics committee of the Medical Faculty of Kiel University, 13/03/2007, ref: A 121/07
Study design
Proof of principle study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/01/2009
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
53
Participant exclusion criteria
1. Age <17 years
2. Gender: Female
3. History of gastrointestinal, hepatic, cardiovascular or renal diseases, smoking, eating disorders
Recruitment start date
01/01/2009
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University of Kiel
Kiel
24118
Germany
Funders
Funder type
Industry
Funder name
Kaneka Corporation (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21774831
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21280176
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23021568
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24996614
Publication citations
-
Results
Fischer A, Schmelzer C, Rimbach G, Niklowitz P, Menke T, Döring F, Association between genetic variants in the Coenzyme Q10 metabolism and Coenzyme Q10 status in humans., BMC Res Notes, 2011, 4, 245, doi: 10.1186/1756-0500-4-245.
-
Results
Schmelzer C, Niklowitz P, Okun JG, Haas D, Menke T, Döring F, Ubiquinol-induced gene expression signatures are translated into altered parameters of erythropoiesis and reduced low density lipoprotein cholesterol levels in humans., IUBMB Life, 2011, 63, 1, 42-48, doi: 10.1002/iub.413.
-
Results
Fischer A, Onur S, Schmelzer C, Döring F, Ubiquinol decreases monocytic expression and DNA methylation of the pro-inflammatory chemokine ligand 2 gene in humans., BMC Res Notes, 2012, 5, 540, doi: 10.1186/1756-0500-5-540.
-
Results
Onur S, Niklowitz P, Jacobs G, Nöthlings U, Lieb W, Menke T, Döring F, Ubiquinol reduces gamma glutamyltransferase as a marker of oxidative stress in humans, BMC Res Notes, 2014, 7, 427, doi: 10.1186/1756-0500-7-427.