Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000047291
Ethics application status
Approved
Date submitted
1/02/2007
Date registered
21/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acceptability and effectiveness of chocolate or tomato extract in reducing blood pressure in people with pre-hypertension: a pilot study.
Scientific title
In people with pre-hypertension, how acceptable and effective are chocolate and tomato extract compared to placebo in reducing blood pressure?
Secondary ID [1] 784 0
na
Universal Trial Number (UTN)
Trial acronym
na
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-hypertension 2124 0
Condition category
Condition code
Cardiovascular 2220 2220 0 0
Hypertension
Cardiovascular 4407 4407 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: 50G of 70% cocoa chocolate orally daily for 2 months
Intervention 2: One capsule of Lyc-o-Mato tomato extract containing 15mg lycopene orally daily for 2 months
Intervention code [1] 1581 0
Treatment: Other
Comparator / control treatment
3. Placebo capsule matching in size, colour and smell the active treatment capsule containing soy oil orally daily for 2 months
Control group
Placebo

Outcomes
Primary outcome [1] 3077 0
Acceptability of each treatment using questionnaires
Timepoint [1] 3077 0
at 8 and 20 weeks
Primary outcome [2] 3078 0
Reduction in blood pressure
Timepoint [2] 3078 0
at 0, 4, 8, 12, 16, 20, 24 weeks
Secondary outcome [1] 5156 0
physical activity by questionnaire
Timepoint [1] 5156 0
0,8,20 weeks
Secondary outcome [2] 8907 0
general health, mood, energy by questionnaire
Timepoint [2] 8907 0
0,8,20 weeks

Eligibility
Key inclusion criteria
Blood pressure 120-139/80-89 mm Hg
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently on treatment for hypertension;
Diabetic or glucose intolerant;
Allergic to or intolerant of tomato or cocoa

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)
Possible participants identified by general practitioner or nurse and invited to participate, screened for inclusion and exclusion criteria, enrolled into trial if criteria met. Randomly assigned to one of the three experimental groups. Allocation was concealed by computer generated random number tables conducted by a statistician off-site and not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinding was assured for participants taking a capsule, either tomato extract or placebo. However, blinding of participants allocated to a chocolate group was impractical. IThe research nurse who assessed outcomes and investigators analysing data were blinded for all treatment groups.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4394 0
Charities/Societies/Foundations
Name [1] 4394 0
Royal Australian College of General Practitioners (RACGP)
Country [1] 4394 0
Australia
Primary sponsor type
Individual
Name
Dr Oliver Frank
Address
Discipline of General Practice
THe University of Adelaide
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 3954 0
Individual
Name [1] 3954 0
Dr Karin Ried
Address [1] 3954 0
Discipline of General Practice
THe University of Adelaide
Adelaide SA 5005
Country [1] 3954 0
Australia
Other collaborator category [1] 534 0
Individual
Name [1] 534 0
Prof Nigel Stocks
Address [1] 534 0
Discipline of General Practice
THe University of Adelaide
Adelaide SA 5005
Country [1] 534 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4202 0
Human Research Ethics Committee University of Adelaide
Ethics committee address [1] 4202 0
Ethics committee country [1] 4202 0
Australia
Date submitted for ethics approval [1] 4202 0
Approval date [1] 4202 0
01/03/2007
Ethics approval number [1] 4202 0
H-015-2007

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

Contacts
Principal investigator
Name 27515 0
Address 27515 0
Country 27515 0
Phone 27515 0
Fax 27515 0
Email 27515 0
Contact person for public queries
Name 10770 0
Dr. Karin Ried
Address 10770 0
Discipline of General Practice
School of Population Health and Clinical Practice
Faculty of Health Sciences
University of Adelaide
SA 5005
Country 10770 0
Australia
Phone 10770 0
+61 8 8303 6281
Fax 10770 0
+61 8 8303 3511
Email 10770 0
[email protected]
Contact person for scientific queries
Name 1698 0
Dr. Karin Ried
Address 1698 0
Discipline of General Practice
School of Population Health and Clinical Practice
Faculty of Health Sciences
University of Adelaide
SA 5005
Country 1698 0
Australia
Phone 1698 0
+61 8 8303 6281
Fax 1698 0
+61 8 8303 3511
Email 1698 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.