Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000434493
Ethics application status
Approved
Date submitted
16/08/2007
Date registered
27/08/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of consumption of lupin kernel flour-enriched foods on weight management
Scientific title
Effects of consumption of lupin kernel flour-enriched foods during and following weight loss on body composition and risk factors for heart disease in overweight men and women
Secondary ID [1] 462 0
Nil
Universal Trial Number (UTN)
Trial acronym
LWL (Lupin Weight Loss Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 2268 0
Overweight 2269 0
Cardiovascular risk reduction 2270 0
Condition category
Condition code
Diet and Nutrition 2360 2360 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High (25-50% incorporation rate) and Low (<1%) lupin kernel flour fortified foods provided and consumed for a period of 12 months. In the high lupin group we are aiming for 60g per day of lupin kernel flour from the foods, contributing approximately an additional 25 grams of protein and 15 grams of fibre per day. In the low lupin (placebo) group we are aiming for <1g per day of lupin kernel flour from the foods, contributing negligible protein and fibre from lupin. This should result in a difference of >20g protein and >10g of fibre per day between the low lupin and
high lupin groups attributed to the difference in incorporation of lupin kernel flour.

Dietetic weight management advice for the first 4 months of the study for both groups.
Intervention code [1] 1979 0
Other interventions
Comparator / control treatment
The placebo treatment involves the consumption of foods with a negligible amount (<1% inclusion rate) of lupin kernel flour in them and dietetic weight management advice.
Control group
Placebo

Outcomes
Primary outcome [1] 3258 0
Change in Body weight
Timepoint [1] 3258 0
Baseline, 4 months, 12 moths
Secondary outcome [1] 5437 0
Change in body composition (Using Dual energy x-ray absorptiometry (DEXA) to measure, bone, muscle and fat mass and Bioelectrical impedance (BIA) scales to measure muscle and fat mass)
Timepoint [1] 5437 0
Baseline, 4 months and 12 months.
Secondary outcome [2] 5438 0
Blood pressure (24hr Ambulatory blood pressure (ABP))
Timepoint [2] 5438 0
Baseline, 4 months and 12 months
Secondary outcome [3] 5439 0
Blood lipids
Timepoint [3] 5439 0
Baseline, 4 months and 12 months.

Eligibility
Key inclusion criteria
Inclusion:
Men and women 20 to 70 years old,
Body Mass Index (BMI) 27-35kg/m2= Weight (in kilograms)/ height² (in meters)
Non-smokers
Healthy
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-current or recent (<12 months) smoking

-body mass index < 27 or > 35 kg/m2,

-history of cardiovascular or peripheral vascular disease,

-diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 6.0 mmol/L,

-treated hypertension or treated dyslipidaemia

-history of asthma, renal, liver or gastrointestinal disease, or gout,

-a psychiatric illness,
-other major illnesses such as cancer,

-systolic blood pressure > 150 mm Hg or diastolic blood pressure >95mm Hg,

-total cholesterol > 6.0 mmol/L or triglycerides > 2.0 mmol/L,

-a change in drug therapy within the previous 3 months, or the likelihood that drug therapy would change during the study,

-women who are pregnant or intend to become pregnant,

-history of severe food allergies especially Lupin,

-current or recent (within previous 6 months) significant weight loss or gain (> 6% of body weight),

-alcohol intake > 140 g per wk for women and > 280 g per wk for men,

-individuals who travel and/or eat away from home regularly,

-inability or unwillingness to consume foods provided.

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 matched for BMI, age and gender then randomly assigned using computer generated random numbers to either the low lupin or high lupin group. The group allocation will be sealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence of random numbers.
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
16/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 224 0
6000-6999

Funding & Sponsors
Funding source category [1] 2517 0
Government body
Name [1] 2517 0
State Government of Western Australia
Country [1] 2517 0
Australia
Primary sponsor type
Government body
Name
State Government of Western Australia
Address
State Government of Western Australia,
WA
Country
Australia
Secondary sponsor category [1] 2281 0
None
Name [1] 2281 0
Address [1] 2281 0
Country [1] 2281 0
Other collaborator category [1] 10 0
University
Name [1] 10 0
University of Western Australia
Address [1] 10 0
School of Medicine & Pharmacology
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country [1] 10 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4431 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 4431 0
Ethics committee country [1] 4431 0
Australia
Date submitted for ethics approval [1] 4431 0
07/05/2007
Approval date [1] 4431 0
23/05/2007
Ethics approval number [1] 4431 0
RA/4/1/1786

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

Contacts
Principal investigator
Name 27989 0
Address 27989 0
Country 27989 0
Phone 27989 0
Fax 27989 0
Email 27989 0
Contact person for public queries
Name 11146 0
Regina Belski
Address 11146 0
School of Medicine & Pharmacology
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country 11146 0
Australia
Phone 11146 0
+61 8 92240344
Fax 11146 0
Email 11146 0
[email protected]
Contact person for scientific queries
Name 2074 0
Jonathan Hodgson
Address 2074 0
School of Medicine & Pharmacology
Medical Research Foundation Building
Level 4, Rear 50 Murray Street
PERTH Western Australia 6000
Country 2074 0
Australia
Phone 2074 0
+61 8 92240267
Fax 2074 0
Email 2074 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.