Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000315011
Ethics application status
Approved
Date submitted
19/04/2010
Date registered
20/04/2010
Date last updated
20/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effects of increasing amounts of protein in test meal on gastrointestinal hormone secretion, appetite and energy intake in lean and overweight subjects
Scientific title
Evaluation of the effects of increasing amounts of protein in an oral preload on gastrointestinal hormone secretion, appetite and energy intake in lean and overweight males
Secondary ID [1] 251633 0
nil
Universal Trial Number (UTN)
U1111-1114-5569
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 257048 0
Condition category
Condition code
Diet and Nutrition 257211 257211 0 0
Obesity
Oral and Gastrointestinal 257226 257226 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four preloads will be administered in a single-blind, randomised fashion. All will comprise of varying quantities of conventional pasta, or high-protein pasta ( for the High Protein preload), with a tomato-based (Leggos (Registered Trademark), neopolitana pasta sauce and yoghurt (Yoplait (Registered Trademark) french vanilla dessert. Whey protein isolate (Pure Nutrition Australia) will be used to increase the protein, cream to increase the fat, and sugar and cornflour to increase the carbohydrate content of the different test meals.
The high protein preload will contain 89g of protein, 22g of fat and 55g of carbohydrate, the medium protein will contain 55g of protein, 33g of fat and 37g of carbohydrate, the high carbohydrate/low protein meal with contain 12g of protein, 28g of fat and 60g of carbohydrate and the high fat meal will contain 16g of protein, 55g of fat and 30g of carbohydrate.
Each subject will consume each of the of the four preloads, once, on four seperate study days (at t=0). They will remain in the department for a further 180 minutes at which point they will be presented with a cold buffet meal (used to determine energy intake). Each study visit will be separated by 3-7days.
The buffet meal, used to determine energy intake, will consist of:
4 slices of wholemeal bread (Sunblest (Registered Trademark))
4 slices of white bread (Sunblest (Registered Trademark))
100g of deli leg ham (Woolworths)
100g of chicken roll shaved (Woolworths)
4 slices of Coon Tasty (Registered Trademark) cheese slices
100g of tomato
100g continental cucumber
100g iceberg lettuce
600ml of water
300ml of Daily Juice (Registered Trademark) unsweetened orange juice
375ml of Farmers Union (Registered Trademark) iced coffee
200g of Yogo (Registered Trademark) chocolate custard
200g of Yoplait (Registered Trademark) strawberry yoghurt
150g Goulburn Valley (Registered Trademark) fruit salad
1 medium red delicious apple
1 medium banana
25g Flora (Registered Trademark) margarine
25g Masterfoods (Registered Trademark) mayonnaise
Intervention code [1] 256224 0
Behaviour
Intervention code [2] 256237 0
Prevention
Comparator / control treatment
NA
Control group
Dose comparison

Outcomes
Primary outcome [1] 258108 0
Energy intake (measured in kJ, from food intake quantified using a buffet meal)
Timepoint [1] 258108 0
T= 210mins on each of the four study visits.
Secondary outcome [1] 263723 0
Plasma hormone levels (Cholecystokinin, Peptide YY)
Timepoint [1] 263723 0
T=-15, 0, 15, 30, 60, 90, 120, 150, 180, 210 on each study visit
Secondary outcome [2] 263724 0
Blood glucose levels (measured using a calibrated glucometer)
Timepoint [2] 263724 0
T=-15, 0, 15, 30, 60, 90, 120, 150, 180, 210 on each study visit
Secondary outcome [3] 263725 0
Appetite ratings; Measured using a validated visual analogue scale (VAS).
Timepoint [3] 263725 0
T=-15, 0, 15, 30, 60, 90, 120, 150, 180, 210 on each study visit
Secondary outcome [4] 263726 0
Macronutrient consumption (measured in kJ using quantified food intake at a buffet meal)
Timepoint [4] 263726 0
T=210mins on each study visit

Eligibility
Key inclusion criteria
Healthy lean and overweight males, who do not exhibit any of the exclusion criteria detailed below
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
-significant gastrointestinal symptoms, disease or surgery
-use of medications which may affect gastrointestinal function, body weight or appetite
-gallbladder, pancreatic, cardiovascular or any respiratory diseases
-high performance athletes
-intake of alcohol of >20g/day
-smoking >10 cigarettes/ day
-lactose or any other food intolerances
-in lean subjects the degree of eating restraint, measured via the restraint component of the Three Factor Eating questionnare will be used as exclusion criteria (subjects with a resraint score >12 will be excluded)

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)
After a phone interview subjects will be invited to visit the Discipline of Medicine, University of Adelaide for a screening visit. Potential subject's height and weight will be measured and they will be required to complete a Three Factor Eating questionnaire to assess for the degree of eating restraint. Subjects will provide written informed consent prior to inclusion. As this is a within subjects design (i.e a crossover study) each subject is required to receive each of the treatments. Subjects will recieve each treatment in a randomised order which was generated by primary investigator. This same investigator prepared the meals and provided them to the subjects. Therefore allocation was not concealed to the investigator. Subjects were blinded to which meal they were receiving.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation table was generated, using www.randomization.com, to determine the order in which subjects received the four different preload treatments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2719 0
5008
Recruitment postcode(s) [2] 2720 0
5014
Recruitment postcode(s) [3] 2721 0
5016
Recruitment postcode(s) [4] 2722 0
5020
Recruitment postcode(s) [5] 2723 0
5021
Recruitment postcode(s) [6] 2724 0
5022
Recruitment postcode(s) [7] 2725 0
5023
Recruitment postcode(s) [8] 2726 0
5024
Recruitment postcode(s) [9] 2727 0
5031
Recruitment postcode(s) [10] 2728 0
5032
Recruitment postcode(s) [11] 2729 0
5033
Recruitment postcode(s) [12] 2730 0
5035
Recruitment postcode(s) [13] 2731 0
5038
Recruitment postcode(s) [14] 2732 0
5039
Recruitment postcode(s) [15] 2733 0
5045
Recruitment postcode(s) [16] 2734 0
5047
Recruitment postcode(s) [17] 2735 0
5049
Recruitment postcode(s) [18] 2736 0
5051
Recruitment postcode(s) [19] 2737 0
5061
Recruitment postcode(s) [20] 2738 0
5062
Recruitment postcode(s) [21] 2739 0
5063
Recruitment postcode(s) [22] 2740 0
5064
Recruitment postcode(s) [23] 2741 0
5065
Recruitment postcode(s) [24] 2742 0
5066
Recruitment postcode(s) [25] 2743 0
5067
Recruitment postcode(s) [26] 2744 0
5068
Recruitment postcode(s) [27] 2745 0
5069
Recruitment postcode(s) [28] 2746 0
5070
Recruitment postcode(s) [29] 2747 0
5075
Recruitment postcode(s) [30] 2829 0
5000

Funding & Sponsors
Funding source category [1] 256740 0
Government body
Name [1] 256740 0
National Health and Medical Research Council
Country [1] 256740 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christine Feinle-Bisset
Address
University of Adelaide, Discipline of Medicine, Level 6, Eleanor Harrald Building, Royal Adelaide Hospital, Frome Rd, Adelaide, South Australia, 5000.
Country
Australia
Secondary sponsor category [1] 256113 0
None
Name [1] 256113 0
Address [1] 256113 0
Country [1] 256113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258755 0
Royal Adelaide Human Research Ethics Committee
Ethics committee address [1] 258755 0
Ethics committee country [1] 258755 0
Australia
Date submitted for ethics approval [1] 258755 0
07/04/2008
Approval date [1] 258755 0
09/04/2008
Ethics approval number [1] 258755 0
080409

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

Contacts
Principal investigator
Name 30991 0
Address 30991 0
Country 30991 0
Phone 30991 0
Fax 30991 0
Email 30991 0
Contact person for public queries
Name 14238 0
Ms Brydie Clarke
Address 14238 0
University of Adelaide, Discipline of Medicine, Level 6, Eleanor Harrald Building, Royal Adelaide Hospital, Frome Rd, Adelaide, South Australia, 5000
Country 14238 0
Australia
Phone 14238 0
+6188225073
Fax 14238 0
Email 14238 0
[email protected]
Contact person for scientific queries
Name 5166 0
A/Prof Christine Feinle-Bisset
Address 5166 0
University of Adelaide, Discipline of Medicine, Level 6, Eleanor Harrald Building, Royal Adelaide Hospital, Frome Rd, Adelaide, South Australia, 5000
Country 5166 0
Australia
Phone 5166 0
+6188225247
Fax 5166 0
Email 5166 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.