ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight/Obesity

Diet & nutrition

Condition category

Condition code

Diet and Nutrition

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

Prevention

Comparator / control treatment

No Applicable

Control group

Active

Outcomes

Primary outcome [1]

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]

180 minutes post-treatment.

Secondary outcome [1]

Visual Analogue Scale (VAS) scores for hunger and fullness.

Timepoint [1]

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]

Visual Analogue Scale (VAS) scores for satisfaction and thoughts of food.

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Address [1]

Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

3rd floor
Unisys Building 
650 Great South Rd Penrose 1051
Private Bag 92-522
Wellesley St Auckland 1010

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/06/2009

Approval date [1]

01/12/2009

Ethics approval number [1]

NTX/09/08/072

Summary

Brief summary

In the study of appetite regulation preload studies are commonly used to assess effects of the energy and macronutrient composition of a meal on subsequent hunger and food intake. In the most commonly used protocol a fixed meal containing a nutrient to be tested is given, followed several hours later by measurement of the energy consumed at an outcome meal. The participants are asked to eat freely from this meal until they are comfortably full – this is termed an ad libitum meal. If the test nutrient decreases hunger it is hypothesised that this can be detected by a decrease in energy intake at this meal. However, despite the importance of the ad lib lunch meal in appetite studies, and the wide use of this method throughout the scientific literature, there is no consensus as to the ideal composition of the meal. For example, it is not known whether the type and choice of foods offered may enhance or restrict the ability to detect changes of hunger induced by a prior test meal. 
It has been suggested that satiety (=feelings of fullness and decreased desire to eat) may be specific to individual sensory properties of food i.e. repeated consumption of a single food item quickly leads to decreased hunger and increased fullness and hence greater satiety. A greater variety of food items provided may be expected to result in greater intake at a meal setting. This phenomenon has become termed “sensory-specific satiety” (SSS). 
The predominance of data identifying the physiological mechanisms which underpin appetite control and the influence of food and nutrients on energy intake has been collected from trials run within a laboratory setting. Despite the preponderance of data in the scientific literature, a number of methodological issues within these trials remain unresolved including the design of outcome meals with the ability to discriminate changes in hunger and satiety through a behavioural change, i.e. food intake.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Katy Wiessing

Address

Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024

Country

New Zealand

Phone

+64 9 630 3744

Fax

+64 9630 5764

k.wiessing@uniservices.auckland.ac.nz

Contact person for scientific queries

Name

Dr Sally Poppitt

Address

Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024

Country

New Zealand

Phone

+64 9 630 5160

Fax

+64 9 630 5764

s.poppitt@auckland.ac.nz

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.

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