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Trial registered on ANZCTR
Registration number
ACTRN12609000538246
Ethics application status
Approved
Date submitted
30/06/2009
Date registered
3/07/2009
Date last updated
3/07/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
The acute effect of four different proteins on metabolic factors and satiety in lean men.
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Scientific title
The acute effect of four different proteins on metabolic factors and satiety in healthy lean men.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Satiety and Obesity
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Condition category
Condition code
Diet and Nutrition
4937
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A randomised cross-over design study which examines the effect of four different protein meals, each containing 50g of protein, on postprandial glucose, insulin and satiety response.
Arm 1: Meal containing 50 g tuna protein Arm 2: Meal containing 50 g egg white protein
Arm 3: Meal containing 50 g Turkey protein
Arm 4: Meal containing 50 g whey protein
The kilojoule, fat and carbohydrate content were all the same in all 4 meals.
Each meal is only consumed once at 8:00 o'clock in morning of the assessment day.
Before each visit, the subjects were instructed to keep a weighed food diary for 3-4 days before the intervention day and were provided with a standard meal to consume the evening before the intervention day. The subjects were asked to fast for 10-12 hours before attending on the intervention day.
Participants attended at Curtin University on four separate occasions with a one week washout period between each visit.
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Intervention code [1]
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Prevention
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Intervention code [2]
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Lifestyle
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Intervention code [3]
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Prevention
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Comparator / control treatment
Whey protein arm
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Control group
Active
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Outcomes
Primary outcome [1]
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To examine the effect of each protein on postprandial glucose and insulin.
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Assessment method [1]
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Timepoint [1]
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Fasting blood samples taken before the test meal and then post-meal (in minutes) at +30, 60, 90 ,120 and 240.
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Secondary outcome [1]
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To compare the effect of each protein on appetite profile (Visual Analogue Scales, VAS)
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Assessment method [1]
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Timepoint [1]
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Visual analogue scale (VAS) completed before the test meal and then post-meal (in minutes) at +30, 60, 90, 120, 180, and 240.
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Secondary outcome [2]
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To compare the effect of each protein on energy intake.
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Assessment method [2]
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Timepoint [2]
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Immediately after completing the Vas questionnaire, subjects were offered an ad lib lunch and ere instructed to eat just
as much till they were satiated. Inake was recorded by weighing and recording of food as eaten in combination with food tables.
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Eligibility
Key inclusion criteria
Lean men between 18-25 body mass index (BMI), Non-smokers, no regular medications, no major illness/disease
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Minimum age
18
Years
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Maximum age
30
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Overweight, smokers, regular medications, diabetes, hypertension, used steroids, cardiovascular event or surgery in last 6 months, renal disease, and consumes more than 2 standard alcoholic drinks/day.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
Four way cross-over design study
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
University
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Name
Curtin University
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Address
GPO Box U1987
Perth WA 6845
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Curtin University Ethics Committee
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Ethics committee address [1]
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GPO Box U1987
PERTH WA 6845
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/03/2004
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Approval date [1]
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04/07/2005
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Ethics approval number [1]
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HR 77/2005
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Summary
Brief summary
Determining which types of proteins are effective in lowering glucose response, promoting a greater insulin response and satiety postprandially (after a meal is consumed) has obvious benefits. There is little conclusive evidence on the postprandial effect of different types of proteins on such metabolic factors and satiety in humans. This study aims to determine the satiety and metabolic responses in relation to glycaemia and insulinaemia of four completely different protein sources, namely fish, poultry, dairy (whey) and egg albumin in healthy men aged between 18 and 30 years.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Sebely Pal
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Address
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GPO Box U1987
PERTH WA 6845
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Country
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Australia
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Phone
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+ 61 8 9266 4755
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Sebely Pal
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Address
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GPO Box U1987
PERTH WA 6845
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Country
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Australia
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Phone
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+61 8 9266 4755
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Fax
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Email
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[email protected]
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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
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No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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