Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001321538
Ethics application status
Approved
Date submitted
27/10/2015
Date registered
2/12/2015
Date last updated
2/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Beverage Study: The effects of consuming different types of sweeteners on blood glucose, insulin, and satiety responses
Scientific title
A randomised crossover intervention to compare the effect of consuming four types of sweeteners on postprandial glucose and insulin concentrations and ad libitum intake in healthy males
Secondary ID [1] 287732 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 296578 0
Obesity 296579 0
Condition category
Condition code
Metabolic and Endocrine 296908 296908 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: sucrose, aspartame, Stevia, and Luo Han Guo. The dosage used in the present study is the dose commonly found in commercial products and all the treatments are matched for sweetness, e.g. 1). 65 g sucrose in 500 mL water; 2). 0.44 g aspartame in 500 mL water; 3). 0.33 g Stevia in 500 mL water; 4). 0.63 g Luo Han Guo in in 500 mL water.

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.

During each test day, participants will be asked to consume a pre-package study breakfast in the morning. The study breakfast consists of a packet of Milo, an apple, a packet of biscuit, and a muesli bar. They will be asked to consume a study preload (e.g. sucrose, aspartame, Stevia or Luo Han Guo drink) within fifteen minutes 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. 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 the 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. Participants will also be given the option whether they would like to have their blood glucose to be monitored the day before and after each test session. If they take up this option, Continuous Glucose Monitoring System (CGMS) insertion will be carried out by a trained researcher the day before each test session and they will return to CNRC on Day 3 for CGMS removal. The sensor will be calibrated using finger prick capillary blood glucose measurements taken at pre-meals (breakfast, lunch, snack, dinner) and before sleeping during the intervention period with the OneTouchUltra'Registered Trademark'2 blood glucose meter (LifeScan,Inc., Milpitas, CA, USA).
Intervention code [1] 293125 0
Prevention
Intervention code [2] 293126 0
Behaviour
Comparator / control treatment
This will be a randomised crossover study where participants will act as their own control. Sucrose will be used as a comparator.
Control group
Active

Outcomes
Primary outcome [1] 296441 0
Blood glucose and insulin concentrations (Composite). Finger prick blood samples will be obtained prospectively for the measurements of blood glucose and insulin. Blood samples will be collected directly into cuvettes for analysing blood glucose concentrations using a Hemocue'Registered Trademark' Glucose 201 Analyser (Helsingborg, Sweden). Blood samples will also be collected into microtubes for the analysis of blood insulin concentrations using Cobas e411 machine.
Timepoint [1] 296441 0
During each test day, 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 the commencement of preload consumption.
Primary outcome [2] 296442 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 [2] 296442 0
Ad libitum lunch. During 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.
Secondary outcome [1] 318451 0
Satiety. On the test 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] 318451 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] 318453 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.
Timepoint [2] 318453 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 for this study are healthy males aged between 21 and 50 years.
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
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 different types of sweeteners on ‘glycaemic response’, ‘insulin response’, ‘appetite’, and ‘energy compensation’. Statistical analyses will be conducted using the Statistical Package for the Social Sciences (SPSS) version 23.0. Two-sided P<0.05 will be considered statistically significant in all cases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 7274 0
Singapore
State/province [1] 7274 0

Funding & Sponsors
Funding source category [1] 292275 0
Government body
Name [1] 292275 0
Singapore Institute for Clinical Sciences, A*STAR
Country [1] 292275 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] 290953 0
None
Name [1] 290953 0
Address [1] 290953 0
Country [1] 290953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293750 0
Singapore National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 293750 0
Ethics committee country [1] 293750 0
Singapore
Date submitted for ethics approval [1] 293750 0
31/07/2015
Approval date [1] 293750 0
07/10/2015
Ethics approval number [1] 293750 0
2015/00750

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

Contacts
Principal investigator
Name 61158 0
Dr Agnes Siew Ling Tey
Address 61158 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 61158 0
Singapore
Phone 61158 0
+65 6407 0741
Fax 61158 0
+65 6774 7134
Email 61158 0
[email protected]
Contact person for public queries
Name 61159 0
Agnes Siew Ling Tey
Address 61159 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 61159 0
Singapore
Phone 61159 0
+65 6407 0741
Fax 61159 0
Email 61159 0
[email protected]
Contact person for scientific queries
Name 61160 0
Agnes Siew Ling Tey
Address 61160 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 61160 0
Singapore
Phone 61160 0
+65 6407 0741
Fax 61160 0
Email 61160 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
EmbaseEffects of non-nutritive (artificial vs natural) sweeteners on 24-h glucose profiles.2017https://dx.doi.org/10.1038/ejcn.2017.37
N.B. These documents automatically identified may not have been verified by the study sponsor.