Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000902594
Ethics application status
Approved
Date submitted
15/07/2015
Date registered
27/08/2015
Date last updated
27/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Munchie Lunch Study: The effects of consuming different types of lunch on satiety in healthy males
Scientific title
A randomised crossover intervention to investigate the dose-response effect of calorie reduction or increment at a lunchtime meal on acute energy compensation in healthy males
Secondary ID [1] 286678 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295022 0
Condition category
Condition code
Diet and Nutrition 295282 295282 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted using a randomised, crossover design.

All participants will be asked to attend a screening session (in order to determine their eligibility) and five test sessions with lunches varying in energy content. During the screening visit, participants will be asked to give informed consent, to complete several questionnaires, and some basic anthropometric measurements such as height, weight, body composition, waist and hip circumferences will be taken. Following this, participants will be asked to attend five test sessions, with a minimum of seven-day washout period between the test sessions. Participants will be asked to consume a pre-package study breakfast (around 500 kcal) in the morning on the test day. The same study breakfast will be provided on all five test days and participants will be asked to finish the entire study breakfast. During each test session, participants will be randomly allocated to receive one of the five test lunches, e.g. 150 kcal, 300 kcal, 600 kcal, 900 kcal or 1200 kcal of noodle soup. Noodle soup has been chosen as the test lunch as it is a popular and typical lunch in Asia. All test lunches contain the same ingredients, e.g. noodle, miso dashi broth, sesame seeds, chicken, zucchini, spring onion, mung bean, sea weed, fish cake, sesame oil, and canola oil, albeit the proportion of each ingredient differs between test lunches. Thus the amount of macronutrient and energy density vary across treatments, ranging from 18-26 g for protein, 4-63 g for fat, 14-136 g for carbohydrate, 0.27-1.81 kcal/g for energy density. The test lunches are matched for palatability, sensory properties, and weight. They will be covertly manipulated and hence participants will be blinded to the treatments they receive. Participants will be asked to consume the entire portion of the test lunch served. They will also be asked to rate their appetite every fifteen minutes for the first hour and every 30 minutes thereafter until they return for their evening meal. Participants are allowed to leave the study site after lunch and they will be asked to return for their evening meal 5 to 5.5 hours after lunch. They will be given a pre-package afternoon snacks before they leave the study site and they are allowed to have the afternoon snacks if they are hungry before the evening meal (optional). Participants are allowed to consume as little or as much food as they wish till they are comfortably full (i.e. ad libitum intake) for the evening meal. On each test day, participants are allowed to consume one black coffee or tea without sugar. All participants will be asked to complete a one-day food diary on the test day in order to monitor their adherence to the study protocol. In addition, all participants will be asked to complete some sensory measures during the study. Participants will also be encouraged to continue their habitual diet and physical activity during the intervention.
Intervention code [1] 291828 0
Prevention
Intervention code [2] 292384 0
Behaviour
Comparator / control treatment
This is a randomised crossover study where participants will act as their own control. The habitual calorie intake for lunch for a male participant will be 600 kcal.
Control group
Active

Outcomes
Primary outcome [1] 295024 0
Energy compensation, i.e. energy intake during an ad libitum evening meal. Ad libitum intake of the evening meal will be measured by weighing the leftovers on the plate. Calories and energy compensation will then be calculated.
Timepoint [1] 295024 0
Ad libitum dinner. During each test day, participants will leave the study site after lunch and they will return to the study site five to six hours later for their evening meal. Participants are allowed to consume any amount of food as they wish during the evening meal (ad libitum intake).
Secondary outcome [1] 314614 0
Satiety. On the testing session days, participants will be asked to record their appetite ratings on a 100 mm visual analogue scale (VAS). The appetite-rating questionnaire will include questions on hunger, thirst, desire to eat, prospective consumption, and fullness.
Timepoint [1] 314614 0
Participants will be asked to rate their appetite before lunch (baseline), every 15 minutes for the first hour after lunch and every 30 minutes thereafter until they return for their evening meal
Secondary outcome [2] 316164 0
Questionnaires on individual characteristics, food choice and preference will be used to determine whether the degree of energy compensation could be explained by these variables.
Timepoint [2] 316164 0
Participants will be asked to complete the following questionnaires: Dutch Eating Behavior Questionnaire, Three Factor Eating Questionnaire, Body Perception Questionnaire, Intuitive Eating Scale, Dietary Practice Questionnaire, Food Choice Questionnaire, Food Preference Questionnaire, and Power of Food Scale during the screening visit.

Eligibility
Key inclusion criteria
The inclusion criteria are healthy males between the ages of 21 and 40 years with a body mass index between 18.5 and 25.0 kg/m2
Minimum age
21 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are as follows,
- People who are taking any medications known to affect appetite or energy metabolism
- Individuals who are currently dieting
- People with allergies to study foods
- Individuals whose body weight has changed more than 5 kilograms in the last 12 months

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)
Allocation concealment will be used. This will be achieved through allocation being performed by a researcher who will have no involvement in the enrollment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a randomisation table generated from Research Randomizer (Version 4.0)
http://www.randomizer.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to provide 90% of power to detect a mean difference of 400 kcal in energy compensation between any of the two treatments using a two-sided significant level of 5%, 17 participants will be required with complete data. Allowing for 30% missing or unusable data, 23 participants will be recruited for this study. Baseline characteristics of the participants will be presented as arithmetic means and standard deviations. Linear mixed models with a random participant effect to account for the underlying correlation between the repeated measures will be used to examine the effects of consuming lunches with different energy content on ‘energy compensation’ and 'satiety'. Statistical analyses will be conducted using Stata 11.1 (StataCorp, College Station, TX, USA). Two-sided P<0.05 will be considered statistically significant in all cases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2015
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment outside Australia
Country [1] 6873 0
Singapore
State/province [1] 6873 0

Funding & Sponsors
Funding source category [1] 291252 0
Government body
Name [1] 291252 0
Singapore Institute for Clinical Sciences, A*STAR
Country [1] 291252 0
Singapore
Primary sponsor type
Government body
Name
Singapore Institute for Clinical Sciences, A*STAR
Address
Brenner Centre for Molecular Medicine
30 Medical Drive
Singapore 117609
Country
Singapore
Secondary sponsor category [1] 289928 0
None
Name [1] 289928 0
Address [1] 289928 0
Country [1] 289928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292814 0
Singapore National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 292814 0
Ethics committee country [1] 292814 0
Singapore
Date submitted for ethics approval [1] 292814 0
Approval date [1] 292814 0
14/05/2015
Ethics approval number [1] 292814 0
2015/00328

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

Contacts
Principal investigator
Name 57142 0
Dr Agnes Siew Ling Tey
Address 57142 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 57142 0
Singapore
Phone 57142 0
+65 6407 0741
Fax 57142 0
+65 6774 7134
Email 57142 0
[email protected]
Contact person for public queries
Name 57143 0
Agnes Siew Ling Tey
Address 57143 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 57143 0
Singapore
Phone 57143 0
+65 6407 0741
Fax 57143 0
+65 6774 7134
Email 57143 0
[email protected]
Contact person for scientific queries
Name 57144 0
Agnes Siew Ling Tey
Address 57144 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 57144 0
Singapore
Phone 57144 0
+65 6407 0741
Fax 57144 0
+65 6774 7134
Email 57144 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
SourceTitleYear of PublicationDOI
EmbaseImpact of dose-response calorie reduction or supplementation of a covertly manipulated lunchtime meal on energy compensation.2016https://dx.doi.org/10.1016/j.physbeh.2016.06.032
N.B. These documents automatically identified may not have been verified by the study sponsor.