Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000433606
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose-response to coenzyme Q10 supplementation with Q-Gel
Scientific title
Change in plasma coenzyme Q10 level after various doses of the coenzyme Q10 supplement Q-Gel in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
None 543 0
Healthy Volunteers 544 0
Condition category
Condition code
Blood 622 622 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four different treatments are to be used in this study. 1)single oral dose of 60 mg of coenzyme Q10 supplement Q-Gel (2 x 30 mg capsules); 2) single oral dose of 150 mg of coenzyme Q10 supplement Q-Gel (5 x 30 mg capsules); 3) single oral dose of 300 mg of coenzyme Q10 supplement Q-Gel (10 x 30 mg capsules); 4) single oral dose of 300 mg of coenzyme Q10 supplement Q-Gel (3 x 100 mg capsules). Each participant will receive all four treatments, one per week for four weeks.

Treatments will be given between 0800 and 0900 hours, after an overnight fast. For all doses, blood samples will be drawn at time 0, 2, 4, 6, 8, and 10 hours after the dose for the measurement of coenzyme Q10 in plasma. Lipid profiles (total cholesterol, LDL- and HDL-cholesterol and triglycerides) will also be measured on all samples.
Intervention code [1] 472 0
None
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 728 0
The increase in plasma CoQ10 after supplementation with varying doses of the CoQ10 supplement Q-Gel, for a period of 10 hours after ingestion of the supplement
Timepoint [1] 728 0
After ingestion of the supplement
Secondary outcome [1] 1493 0
The increase in plasma CoQ10 after supplementation given as 3 x 300 mg supplements and 10 x 30 mg, for a period of 10 hours after ingestion of the supplements, will be compared.
Timepoint [1] 1493 0

Eligibility
Key inclusion criteria
Healthy.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Smoker. Taking any supplements or prescription medication on a regular basis. Intercurrent illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment is used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random letters (A-D), allocated one letter to each treatment were pulled from a hat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 202 0
New Zealand
State/province [1] 202 0

Funding & Sponsors
Funding source category [1] 680 0
Charities/Societies/Foundations
Name [1] 680 0
New Zealand Heart Foundation
Country [1] 680 0
New Zealand
Primary sponsor type
Government body
Name
Canterbury Health Laboratories
Address
Country
New Zealand
Secondary sponsor category [1] 569 0
None
Name [1] 569 0
N/A
Address [1] 569 0
Country [1] 569 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35583 0
Address 35583 0
Country 35583 0
Phone 35583 0
Fax 35583 0
Email 35583 0
Contact person for public queries
Name 9661 0
Sarah Molyneux
Address 9661 0
Biochemistry Unit
Canterbury Health Laboratories
PO Box 151
Christchurch 8001
Country 9661 0
New Zealand
Phone 9661 0
+64 3 3641594
Fax 9661 0
Email 9661 0
[email protected]
Contact person for scientific queries
Name 589 0
Sarah Molyneux
Address 589 0
Biochemistry Unit
Canterbury Health Laboratories
PO Box 151
Christchurch 8001
Country 589 0
New Zealand
Phone 589 0
+64 3 3641594
Fax 589 0
Email 589 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.