Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000130460
Ethics application status
Approved
Date submitted
14/02/2007
Date registered
15/02/2007
Date last updated
27/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of a combination of fenugreek/phaseolamin as a new weight loss agent
Scientific title
A pilot study to investigate the efficacy and tolerability of a combination of fenugreek/phaseolamin as a potential weight loss agent when given as part of a muesli bar in moderately obese patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1622 0
Condition category
Condition code
Diet and Nutrition 1730 1730 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive one treatment three times a day (~20min before each meal) for twelve weeks: the treatment muesli bar containing Fenulife 43 (3g/bar) and phaseolamin (0.23g/bar).
Intervention code [1] 1587 0
Treatment: Other
Comparator / control treatment
Participants will receive one treatment three times a day (~20min before each meal) for twelve weeks: the control muesli bar with no Fenulife 43 and phaseolamin.
Control group
Placebo

Outcomes
Primary outcome [1] 2403 0
Weight loss
Timepoint [1] 2403 0
At 12 weeks
Secondary outcome [1] 4177 0
Weight loss
Timepoint [1] 4177 0
At 4 and 8 weeks
Secondary outcome [2] 4178 0
Blood hormal changes and HbA1C changes
Timepoint [2] 4178 0
At 12 weeks
Secondary outcome [3] 4179 0
Tolerability data
Timepoint [3] 4179 0
At 4, 8 and 12 weeks

Eligibility
Key inclusion criteria
Overweight as defined by body mass index 30-40kg/m2Generally healthyWeight stable over previous 3 monthsWilling and able to give written informed consent.
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetic (receiving pharmacological treatments for diabetes)Pregnant, breastfeeding, or intending to become pregnant during the studyAny medications, or medical conditions that might, in the opinion of the Principal Investigator, affect participant safety or outcomeCurrently on an alternative weight loss programme or planning to start a programme during the study durationHas a pace-makerPlanning international travel during the study.

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 will be screened and enrolled on confirmation of eligibility. Randomisation to the intervention will be by computer access to a secure schedule administered by a third party process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer generated by a third party and accessed by staff at the time of enrolment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The subjects and assessors will be blinded. Data entry will be blinded but data analysis will not be blinded due to the 2:1 (active:placebo) weighting.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment outside Australia
Country [1] 480 0
New Zealand
State/province [1] 480 0

Funding & Sponsors
Funding source category [1] 1879 0
Commercial sector/Industry
Name [1] 1879 0
Southern European Health Marketing Ltd
Country [1] 1879 0
Gibraltar
Primary sponsor type
Commercial sector/Industry
Name
Southern European Health Marketing Ltd
Address
Heritage House
235 Main Street
Country
Gibraltar
Secondary sponsor category [1] 1694 0
None
Name [1] 1694 0
Address [1] 1694 0
Country [1] 1694 0
Other collaborator category [1] 215 0
Charities/Societies/Foundations
Name [1] 215 0
Medical Research Institute of New Zealand (MRINZ)
Address [1] 215 0
PO Box 10055
The Terrace
Wellington
Country [1] 215 0
New Zealand
Other collaborator category [2] 216 0
Other
Name [2] 216 0
P3 Research
Address [2] 216 0
Promed House
Suite 11
71 - 10th Avenue
Tauranga
Country [2] 216 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3504 0
Multi-Region Ethics Committee
Ethics committee address [1] 3504 0
The Terrace, Wellington
Ethics committee country [1] 3504 0
New Zealand
Date submitted for ethics approval [1] 3504 0
Approval date [1] 3504 0
10/04/2007
Ethics approval number [1] 3504 0

Summary
Brief summary
This study is looking at whether a new investigational product (a combination of fenugreek and phaseolamin in a muesli bar taken for 12 weeks) is effective at causing weight loss. Specific components in the blood are also measured to see if the product has any effect on them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27521 0
Address 27521 0
Country 27521 0
Phone 27521 0
Fax 27521 0
Email 27521 0
Contact person for public queries
Name 10776 0
Professor Richard Beasley
Address 10776 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington
Country 10776 0
New Zealand
Phone 10776 0
+64 4 472 9199
Fax 10776 0
Email 10776 0
richard.beasley@mrinz.ac.nz
Contact person for scientific queries
Name 1704 0
Professor Richard Beasley
Address 1704 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington
Country 1704 0
New Zealand
Phone 1704 0
+64 4 4729199
Fax 1704 0
Email 1704 0
richard.beasley@mrinz.ac.nz

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
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Documents added automatically
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