Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000971033
Ethics application status
Approved
Date submitted
11/11/2010
Date registered
11/11/2010
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does meal composition affect the ability to detect changes in appetite regulation in a laboratory setting?
Scientific title
Small vs. large buffet meals: A methodological study investigating the effect of food choice at an ad libitum meal on the ability to detect changes in appetite within a laboratory setting.
Secondary ID [1] 253071 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/Obesity 252355 0
Diet & nutrition 252359 0
Condition category
Condition code
Diet and Nutrition 256544 256544 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will investigate the effect of meal size and choice on energy intake at an ad libitum buffet lunch following 2 test meal challenges comprising (i) a low-energy, hunger-inducing test breakfast and (ii) a high-energy, hunger-suppressing test breakfast.

The trial design will be a 4 arm cross-over, single day intervention study comprising 30 healthy lean male subjects (aged 18-60 years). Participants will be given either a low energy (0.5MJ) or high energy (4.0MJ) test breakfast (matched for protein, fat and carbohydrate (CHO) composition (energy %)), followed by either a restricted, or multi-item buffet lunch 3 hours later. There will be a minimum washout period of 2 days in between interventions.
Each participant will complete all study arms in a randomized order according to a Latin square design.

The 4 interventions are:
1. Low energy (0.5MJ) breakfast, followed by restricted-item ad libitum lunch meal.
2. Low energy (0.5MJ) breakfast, followed by multi-item ad libitum lunch meal.
3. High energy (4.0MJ) breakfast, followed by restricted-item ad libitum lunch meal.
4. High energy (4.0MJ) breakfast, followed by multi-item ad libitum lunch meal.

The breakfast meals will comprise typical breakfast food items consumed in New Zealand. The macronutrient compositions of the breakfasts will be:
1. Hunger-inducing Breakfast (0.5MJ)~30% Fat; ~55% CHO; 12-15% Protein.
2. Hunger-suppressing Breakfast (4.0MJ) ~30% Fat; ~55% CHO; 12-15% Protein.

All breakfast items provided must be consumed by participants.

The ad libitum lunch will comprise either a restricted-item buffet or a multi-item buffet. The multi-item buffet will comprise a hot savoury dish, a sandwich option, a sweet option, fruit and water. The restricted-item lunch will comprise the hot savoury dish, plus water. The macronutrient composition of both buffet meals will be approximately: Fat 20-30%; Protein 10-20% and Carbohydrate 50-60%.
Both buffet lunch meals will provide items served in moderate excess and participants will be instructed to eat as much of all food items available until they feel comfortably full.
Intervention code [1] 255667 0
Behaviour
Intervention code [2] 257590 0
Lifestyle
Intervention code [3] 257591 0
Prevention
Comparator / control treatment
No Applicable
Control group
Active

Outcomes
Primary outcome [1] 253427 0
The primary outcome is energy intake at the ad libitum lunch meal following the test meal (hunger-inducing or hunger-suppressing breakfasts). Lunch items will be weighed by research staff pre- and post-meal, and energy, fat, carbohydrate and protein intake calculated using the dietary program Foodworks
Timepoint [1] 253427 0
180 minutes post-treatment.
Secondary outcome [1] 262549 0
Visual Analogue Scale (VAS) scores for hunger and fullness.
Timepoint [1] 262549 0
t= -5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270 and 330 mins. These time points are set assuming t=0 is the time the breakfast meal is administered. Therefore any negative time points refer to a VAS measurement taken that many minutes before the breakfast meal. Positive time points are for VAS measurements at that number of minutes post-breakfast.
Secondary outcome [2] 262550 0
Visual Analogue Scale (VAS) scores for satisfaction and thoughts of food.
Timepoint [2] 262550 0
t= -5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270 and 330 mins. These time points are set assuming t=0 is the time the breakfast meal is administered. Therefore any negative time points refer to a VAS measurement taken that many minutes before the breakfast meal. Positive time points are for VAS measurements at that number of minutes post-breakfast.

Eligibility
Key inclusion criteria
1. Male
2. Age 18-60 years.
3. Lean (as defined by BMI in the range of 18-25 kg/m²).
4.Healthy, as ascertained by self-report.
5. Desire to participate in clinical trial.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant endocrine, cardiovascular, gastrointestinal, metabolic disease or cancer/s including a history of these diseases as determined by the study physician.
2. Smokers or ex-smokers who had quit within the previous 6 months.
3. Weight loss/gain of 5kg within the previous 6 months.
4. Taking part in an active diet program such as Jenny Craig, Weight Watchers, Slim Sure, Atkins Diet, South Beach Diet etc.
5. Taking medications for weight loss or other conditions known to affect appetite regulation.
6. Any medical conditions known to affect appetite related research parameters.
7. Depression or any other anxiety disorder known to affect appetite.
8. Hypersensitivities or allergies to any foods or ingredients included in the study.
9. Blood Pressure > 160/90 mmHg.
10. Unwilling/unable to comply with study protocol.
11. Participating in another clinical intervention trial.

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)
This is a randomised, cross-over trial. Randomisation is carried out using a Latin square design, whereby next patient registered is allocated to the sequential randomisation code.
All subjects complete all 4 intervention arms. The order in which they are randomized determines the order that they will be presented with each treatment.
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A Latin square will be used to randomise the subjects to each of the 4 intervention arms. Each participant is randomized to complete all 4 intervention arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2357 0
New Zealand
State/province [1] 2357 0
Auckland

Funding & Sponsors
Funding source category [1] 256145 0
University
Name [1] 256145 0
University of Auckland
Country [1] 256145 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country
New Zealand
Secondary sponsor category [1] 251488 0
None
Name [1] 251488 0
Address [1] 251488 0
Country [1] 251488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258239 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258239 0
Ethics committee country [1] 258239 0
New Zealand
Date submitted for ethics approval [1] 258239 0
26/06/2009
Approval date [1] 258239 0
01/12/2009
Ethics approval number [1] 258239 0
NTX/09/08/072

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

Contacts
Principal investigator
Name 30593 0
Address 30593 0
Country 30593 0
Phone 30593 0
Fax 30593 0
Email 30593 0
Contact person for public queries
Name 13840 0
Katy Wiessing
Address 13840 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country 13840 0
New Zealand
Phone 13840 0
+64 9 630 3744
Fax 13840 0
+64 9630 5764
Email 13840 0
[email protected]
Contact person for scientific queries
Name 4768 0
Dr Sally Poppitt
Address 4768 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country 4768 0
New Zealand
Phone 4768 0
+64 9 630 5160
Fax 4768 0
+64 9 630 5764
Email 4768 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.