Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001527459
Ethics application status
Approved
Date submitted
1/11/2016
Date registered
7/11/2016
Date last updated
23/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the plasma levels and safety of coenzyme Q10 from 4 different formulations in healthy adult volunteers.
Scientific title
A comparison of the plasma levels and safety of coenzyme Q10 from 4 different formulations in healthy adult volunteers.
Secondary ID [1] 290426 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CoQ10 deficiency 300766 0
Condition category
Condition code
Diet and Nutrition 300605 300605 0 0
Other diet and nutrition disorders
Alternative and Complementary Medicine 300606 300606 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the absorption characteristics of FOUR Coenzyme Q10 PRODUCTS. ONE Coenzyme Q10 preparation will be self administered (orally) on Day 1 of each week. All participants will be allocated the same preparation each day, rotating products each week for 4 weeks. Participants will receive the four products in the order listed below. Allocation: non-randomised, Treatment Endpoint: Characteristics of Coenzyme Q10 in Blood levels, Intervention Model: oro-buccal or oral administration, Masking: non-blinded, Primary Purpose: absorption characteristics in blood plasma. Clinical Trial Coordinator to supervise dose administration and any adverse effects. Coenzyme Q10 preparations include:
1) Blackmores CoQ10= 150mg
2) Bioceuticals CoQ10 Liposome= 40mg
3) Bioceuticals Ubiquinol BioActive = 150mg
4) Medlab Clinicals NanoCelle CoQ10= 30mg
Intervention code [1] 296265 0
Treatment: Other
Comparator / control treatment
Coenzyme Q10 preparations include:
1) Blackmores CoQ10= 150mg
2) Bioceuticals CoQ10 Liposome= 40mg
3) Bioceuticals Ubiquinol BioActive = 150mg
4) Medlab Clinicals NanoCelle CoQ10= 30mg
Control group
Active

Outcomes
Primary outcome [1] 300020 0
CoQ10 plasma serum measurement
Timepoint [1] 300020 0
Blood draws at baseline (0), 30, 60, 120, 180, 240 and 360 minutes via cannulation
Secondary outcome [1] 328817 0
Safety - Documentation of any adverse events. Side effects may include: stomach upset, loss of appetite, nausea, vomiting, and diarrhoea. CTC to report participants post administration by direct observation
Timepoint [1] 328817 0
Clinical Trial Coordinator to document any adverse events: subject to participant. Continuous monitoring after dose administered to 24 hours post administration.

Eligibility
Key inclusion criteria
1) Participants > 18 years of age at time of entry on study
2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
3) Participants agree to undergo venipuncture on multiple occasions or have a catheter inserted
4) Participants agree to adhere to the study protocol
5) No history of any chronic diseases
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs
2) Any chronic diseases
3) Alcohol abuse
4) Pregnant or nursing an infant
5) Have not been prescribed (medications) or have administered Coenzyme Q10 or any other supplement or vitamin or mineral or herbal medicine in the last week (note: participation will include a 1 week washout period)
6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant
7) The use of illicit drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
11/09/2017
Date of last participant enrolment
Anticipated
31/10/2017
Actual
10/11/2017
Date of last data collection
Anticipated
Actual
15/11/2017
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294831 0
Commercial sector/Industry
Name [1] 294831 0
Medlab Clinical
Country [1] 294831 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, NSW, 2015
Country
Australia
Secondary sponsor category [1] 293673 0
None
Name [1] 293673 0
Address [1] 293673 0
Country [1] 293673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296219 0
National Institute Of Integrative Medicine
Ethics committee address [1] 296219 0
11-23 Burwood Rd, Hawthorn, VIC, 3122
Ethics committee country [1] 296219 0
Australia
Date submitted for ethics approval [1] 296219 0
Approval date [1] 296219 0
09/09/2016
Ethics approval number [1] 296219 0
0036E_2016

Summary
Brief summary
The aim of this study is to evaluate the absorption characteristics of FOUR COENZYME Q10 PRODUCTS. As such this study proposes to evaluate the absorption characteristics of these products by measuring the plasma concentrations following an oral dose. There is significant interest from researchers, general practitioners and the public re: the administration of Coenzyme Q10 supplements for health maintenance or disease treatments such as those with mild to moderate cardiovascular disease, and what differences exist in the absorption characteristics of different formulations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70038 0
Prof Luis Vitetta
Address 70038 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 70038 0
Australia
Phone 70038 0
+61 02 8188 0311
Fax 70038 0
Email 70038 0
[email protected]
Contact person for public queries
Name 70039 0
Miss Serena Dal Forno
Address 70039 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 70039 0
Australia
Phone 70039 0
+61 02 8188 0311 Ext. 120
Fax 70039 0
Email 70039 0
[email protected]
Contact person for scientific queries
Name 70040 0
Prof Luis Vitetta
Address 70040 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 70040 0
Australia
Phone 70040 0
+61 02 8188 0311
Fax 70040 0
Email 70040 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe plasma bioavailability of coenzyme Q10 absorbed from the gut and the oral mucosa.2018https://dx.doi.org/10.3390/jfb9040073
N.B. These documents automatically identified may not have been verified by the study sponsor.