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Trial registered on ANZCTR


Registration number
ACTRN12616001128482
Ethics application status
Approved
Date submitted
2/08/2016
Date registered
18/08/2016
Date last updated
18/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of consuming preloads which differ in energy density (low vs. high) and taste quality (savoury vs. sweet) on postprandial glucose response and energy compensation
Scientific title
A randomised crossover intervention to compare the effects of consuming preloads which differ in energy density (low vs. high) and taste quality (savoury vs. sweet) on postprandial glucose response and energy compensation in healthy males
Secondary ID [1] 289811 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 299735 0
Diabetes 299736 0
Condition category
Condition code
Diet and Nutrition 299669 299669 0 0
Obesity
Metabolic and Endocrine 299789 299789 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted using a randomised crossover design with four treatments: low energy dense savoury preload (around 50 kcal with monosodium glutamate (MSG) and inosine 5’-monophosphate (IMP)), low energy dense sweet preload (around 50 kcal with sucralose), high energy dense savoury preload (around 250 kcal with MSG and IMP), and high energy dense sweet preload (around 250 kcal with sucralose).

All potential participants will be asked to attend a screening session after a 10-hour overnight fast for consenting and screening procedures. Some basic anthropometric measurements such as height, weight, waist and hip circumferences will be taken. Body composition will be measured using Tanita BC-418 machine and BODPOD. Blood pressure will be taken using an automated blood pressure monitor. After the screening visit, participants will be asked to attend four test sessions, with a minimum of five-day washout period between the test sessions.

On each test day, participants will be asked to consume a pre-package study breakfast outside Clinical Nutrition Research Centre (CNRC) between 8 am and 9 am. The study breakfast consists of a packet of Milo, an apple, a packet of biscuit, and a muesli bar. Participants will be asked to arrive at CNRC three hours after breakfast (between 11 am and 12 pm), where they will be provided with a study preload which must be consumed within a 15-minute time period. The preload is made up of soup with ingredients such as yam, sweet potato, corn, and snow fungus. Participants will be provided with an ad libitum lunch an hour after the commencement of preload consumption, where they are allowed to consume as much or as little as they wish until they feel comfortably full. Food consumption will be supervised by research staff. Fingerprick blood samples will be obtained at baseline (prior to preload consumption), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, and 180 minutes after commencement of preload consumption. Participants will be asked to complete an appetite-rating questionnaire at the same time points. All participants will be asked to complete a physical activity questionnaire and one-day diet record a day before their test day and the actual test day.
Intervention code [1] 295488 0
Prevention
Intervention code [2] 295489 0
Behaviour
Intervention code [3] 295596 0
Lifestyle
Comparator / control treatment
This will be a randomised crossover study where participants will act as their own control. This study consists of four treatments: low energy dense savoury preload (around 50 kcal with MSG and IMP), low energy dense sweet preload (around 50 kcal with sucralose), high energy dense savoury preload (around 250 kcal with MSG and IMP), and high energy dense sweet preload (around 250 kcal with sucralose).
Control group
Active

Outcomes
Primary outcome [1] 299131 0
Energy compensation, i.e. energy intake during an ad libitum lunch meal. Ad libitum intake of the lunch meal will be measured by weighing the leftovers on the plate. Energy compensation will then be calculated.
Timepoint [1] 299131 0
Ad libitum lunch. On each test day, participants will be asked to consume a study preload in mid-morning and they will be provided with an ad libitum lunch an hour later, where they are allowed to consume as much or as little food as they wish until they feel comfortably full.
Primary outcome [2] 299132 0
Blood glucose response. Fingerprick blood samples will be obtained prospectively for blood glucose measurement. Blood samples will be collected directly into cuvettes for analysing blood glucose concentrations using a Hemocue Glucose 201 Analyser (Helsinborg, Sweden).
Timepoint [2] 299132 0
Fingerprick blood samples will be collected at baseline (prior to preload consumption), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, and 180 minutes after commencement of preload consumption.
Secondary outcome [1] 326281 0
Satiety response. During each test session, participants will be asked to record their appetite (e.g. hunger, thirst, desire to eat, prospective consumption, fullness, etc.) on a 100 mm visual analogue scale.
Timepoint [1] 326281 0
Participants will be asked to rate their appetite every 15 minutes for the first hour after commencement of preload consumption and every 30 minutes for the subsequent two hours, nine timepoints in total.
Secondary outcome [2] 326285 0
Questionnaires on individual characteristics, food choice and preference (Composite) will be used to determine whether the degree of energy compensation could be explained by these variables. These questionnaires will include Dutch Eating Behaviour 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.
Timepoint [2] 326285 0
Participants will be asked to complete the questionnaires at baseline.

Eligibility
Key inclusion criteria
The inclusion criteria for this study are healthy males aged between 21 and 50 years with normal BMI (18.5 to 25.0 kg/m2).
Minimum age
21 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are as follows,
(a) People with major chronic disease such as heart disease, cancer or diabetes mellitus
(b) Individuals whose body weight has changed more than 5 kilograms in the last 12 months
(c) People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
(d) Individuals who are currently dieting
(e) People with intolerance or allergy to study foods

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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our previous study looking at blood glucose response to liquids in a similar population group (Tey et al., 2016), it has been calculated that in order to have 90% power at the two-sided 0.05 level to detect a difference of 30% in total AUC for glucose between the treatments, 25 participants will be required with full data. Allowing for an approximate 20% dropout rate, 30 participants will be required at baseline.

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 energy density and taste quality on ‘energy compensation’, ‘glycaemic response’, and ‘appetite’. Two-sided P<0.05 will be considered statistically significant in all cases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/08/2016
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] 8067 0
Singapore
State/province [1] 8067 0

Funding & Sponsors
Funding source category [1] 294200 0
Government body
Name [1] 294200 0
Singapore Institute for Clinical Sciences, A*STAR
Country [1] 294200 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] 293029 0
None
Name [1] 293029 0
Address [1] 293029 0
Country [1] 293029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295603 0
Singapore National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 295603 0
Ethics committee country [1] 295603 0
Singapore
Date submitted for ethics approval [1] 295603 0
31/07/2015
Approval date [1] 295603 0
13/10/2015
Ethics approval number [1] 295603 0
2015/00749

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

Contacts
Principal investigator
Name 67898 0
Dr Agnes Siew Ling Tey
Address 67898 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 67898 0
Singapore
Phone 67898 0
+6564070741
Fax 67898 0
+6567747134
Email 67898 0
siewling_tey@sics.a-star.edu.sg
Contact person for public queries
Name 67899 0
Agnes Siew Ling Tey
Address 67899 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 67899 0
Singapore
Phone 67899 0
+6564070741
Fax 67899 0
+6567747134
Email 67899 0
siewling_tey@sics.a-star.edu.sg
Contact person for scientific queries
Name 67900 0
Agnes Siew Ling Tey
Address 67900 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 67900 0
Singapore
Phone 67900 0
+6564070741
Fax 67900 0
+6567747134
Email 67900 0
siewling_tey@sics.a-star.edu.sg

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
EmbaseEffects of consuming preloads with different energy density and taste quality on energy intake and postprandial blood glucose.2018https://dx.doi.org/10.3390/nu10020161
N.B. These documents automatically identified may not have been verified by the study sponsor.