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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.
Scientific title
The acute effect of four different proteins on metabolic factors and satiety in healthy lean men.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Satiety and Obesity 4635 0
Condition category
Condition code
Diet and Nutrition 4937 4937 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4395 0
Prevention
Intervention code [2] 236846 0
Lifestyle
Intervention code [3] 236860 0
Prevention
Comparator / control treatment
Whey protein arm
Control group
Active

Outcomes
Primary outcome [1] 5784 0
To examine the effect of each protein on postprandial glucose and insulin.
Timepoint [1] 5784 0
Fasting blood samples taken before the test meal and then post-meal (in minutes) at +30, 60, 90 ,120 and 240.
Secondary outcome [1] 241763 0
To compare the effect of each protein on appetite profile (Visual Analogue Scales, VAS)
Timepoint [1] 241763 0
Visual analogue scale (VAS) completed before the test meal and then post-meal (in minutes) at +30, 60, 90, 120, 180, and 240.
Secondary outcome [2] 244642 0
To compare the effect of each protein on energy intake.
Timepoint [2] 244642 0
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.

Eligibility
Key inclusion criteria
Lean men between 18-25 body mass index (BMI), Non-smokers, no regular medications, no major illness/disease
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Four way cross-over design study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4817 0
Self funded/Unfunded
Name [1] 4817 0
Country [1] 4817 0
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4358 0
None
Name [1] 4358 0
Address [1] 4358 0
Country [1] 4358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6865 0
Curtin University Ethics Committee
Ethics committee address [1] 6865 0
Ethics committee country [1] 6865 0
Australia
Date submitted for ethics approval [1] 6865 0
01/03/2004
Approval date [1] 6865 0
04/07/2005
Ethics approval number [1] 6865 0
HR 77/2005

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

Contacts
Principal investigator
Name 29514 0
Address 29514 0
Country 29514 0
Phone 29514 0
Fax 29514 0
Email 29514 0
Contact person for public queries
Name 12761 0
Dr Sebely Pal
Address 12761 0
GPO Box U1987
PERTH WA 6845
Country 12761 0
Australia
Phone 12761 0
+ 61 8 9266 4755
Fax 12761 0
Email 12761 0
s.pal@curtin.edu.au
Contact person for scientific queries
Name 3689 0
Dr Sebely Pal
Address 3689 0
GPO Box U1987
PERTH WA 6845
Country 3689 0
Australia
Phone 3689 0
+61 8 9266 4755
Fax 3689 0
Email 3689 0
s.pal@curtin.edu.au

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.