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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000902594
Date of registration: 27/08/2015
Prospective Registration: No
Primary sponsor: Singapore Institute for Clinical Sciences, A*STAR
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
Date of first enrolment: 01/08/2015
Target sample size: 23
Recruitment status: Recruiting
URL:  https://anzctr.org.au/ACTRN12615000902594.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Singapore
Contacts
Name: Dr Agnes Siew Ling Tey   
Address:  14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599 Singapore
Telephone: +65 6407 0741
Email: siewling_tey@sics.a-star.edu.sg
Affiliation: 
Name: Dr Agnes Siew Ling Tey   
Address:  14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599 Singapore
Telephone: +65 6407 0741
Email: siewling_tey@sics.a-star.edu.sg
Affiliation: 
Key inclusion & exclusion criteria
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
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


Age minimum: 21 Years
Age maximum: 40 Years
Gender: Males
Health Condition(s) or Problem(s) studied
Obesity;
Obesity
Diet and Nutrition - Obesity
Intervention(s)
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
Primary Outcome(s)
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. [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(s)
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.
[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. ]
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.[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 ID(s)
Nil
Source(s) of Monetary Support
Singapore Institute for Clinical Sciences, A*STAR
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Singapore National Healthcare Group Domain Specific Review Board
Results
Results available:
Date Posted:
Date Completed:
URL:
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