Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000792224
Ethics application status
Approved
Date submitted
9/09/2009
Date registered
10/09/2009
Date last updated
10/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose related effects of cocoa flavanols on blood pressure
Scientific title
Dose related effects of cocoa flavanols on blood pressure in a borderline hypertensive population
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension / elevated blood pressure 243674 0
Condition category
Condition code
Cardiovascular 239944 239944 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of four doses of cocoa flavanols in cocoa based reconstituted drink. Doses are 33, 372, 712 or 1052 mg/d. Each dose is delivered in a single beverge once per day for 6 weeks. Doses are consistent within each treatment group for the duration of the 6 week intervention.
Intervention code [1] 241223 0
Treatment: Other
Comparator / control treatment
Low-flavanol cocoa beverage (33mg -representing a portion of normal daily dose from foods). Consumed in a single beverage once per day for 6 weeks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 240750 0
24 hour blood pressures as assessed by ambulatory monitoring (including mean, systolic and diastolic pressures).
Timepoint [1] 240750 0
baseline (pre-intervention), 3 weeks and 6 week post randomisation.
Secondary outcome [1] 257405 0
Day-time and night-time blood pressures as assessed by ambulatory monitoring(including mean, systolic and diastolic pressures). Day time blood pressure is recorded from 7am to 11pm (16 hours) and night time from 11pm to 7am (8 hours).
Timepoint [1] 257405 0
baseline (pre-intervention), 3 weeks and 6 week post randomisation.
Secondary outcome [2] 257406 0
Seated clinic blood pressure as assessed by occillometry (including mean, systolic and diastolic pressures).
Timepoint [2] 257406 0
baseline (pre-intervention), 3 weeks and 6 week post randomisation.

Eligibility
Key inclusion criteria
-Adult Male and post menopausal females
-Systolic blood pressure 130-160mmHg and/or diastolic blood pressure 85-100mmHg.
-Otherwise healthy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Known diagnosis of cardiovascular disease (or a history of cardiovascular or cerebrovascular incidents).
-Diabetes (Type 1 or Type 2) or were taking prescribed anti-diabetic medication.
-Renal failure.
-Taking blood pressure lowering medication or dietary supplements that may influence blood pressure (i.e. fish oil, liquorice, polyphenols) in the preceding 3 months,
-Intolerance to alkaloids (caffeine, theobromine) or dairy.
-Currently smoking or using nicotine replacement therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were block-matched by the minimisation convention on blood pressure, gender, age and body mass index into four treatment groups. These groups were randomised to consume the various doses of cocoa flavanols. Group allocation was performed by a member of the research team who had no contact with participants and was not privy to treatment allocation. Random treatment allocation to groups was administered by another member of the research staff that did not have contact with the participants and the treatment coding was stored electronically secured from access by all other research team members.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243614 0
Commercial sector/Industry
Name [1] 243614 0
Mars Inc (via Australian Government Funded Food Innovation Grant)
Country [1] 243614 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Howe
Address
Nutritional Physiology Research Centre University of South Australia, PO Box 2471 Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 237063 0
Individual
Name [1] 237063 0
Mr Kade Davison
Address [1] 237063 0
Nutritional Physiology Research Centre University of South Australia, PO Box 2471 Adelaide, South Australia, 5001
Country [1] 237063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243741 0
University of South Australia HUman Research Ethics Committee
Ethics committee address [1] 243741 0
Ethics committee country [1] 243741 0
Australia
Date submitted for ethics approval [1] 243741 0
Approval date [1] 243741 0
28/02/2007
Ethics approval number [1] 243741 0
P290/06

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

Contacts
Principal investigator
Name 30153 0
Address 30153 0
Country 30153 0
Phone 30153 0
Fax 30153 0
Email 30153 0
Contact person for public queries
Name 13400 0
Mr Kade Davison
Address 13400 0
Southern Cross University
Rifle Range Road
East Lismore
NSW, 2480
Country 13400 0
Australia
Phone 13400 0
+612 6620 3763
Fax 13400 0
Email 13400 0
[email protected]
Contact person for scientific queries
Name 4328 0
Mr Kade Davison
Address 4328 0
Southern Cross University
Rifle Range Road
East Lismore
NSW, 2480
Country 4328 0
Australia
Phone 4328 0
+612 6620 3763
Fax 4328 0
Email 4328 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.