Condition category
Not Applicable
Date applied
18/06/2012
Date assigned
29/06/2012
Last edited
24/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 below 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

Sponsor information

Organisation

Kaneka Corporation (Japan)

Sponsor details

c/o Kazunori Hosoe
3-2-4
Nakanoshima
Kita-ku
Osaka
530-8288
Japan

Sponsor type

Industry

Website

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes