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Trial registered on ANZCTR


Registration number
ACTRN12614000879662
Ethics application status
Approved
Date submitted
29/07/2014
Date registered
19/08/2014
Date last updated
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does artificial sweetener affect energy expenditure and food intake?
Scientific title
Effects of preloads sweetened with sucrose or sucralose on post-prandial energy expenditure, substrate utilisation, appetite, and daily food intake of healthy adults
Secondary ID [1] 285079 0
None
Universal Trial Number (UTN)
U1111-1159-8341
Trial acronym
The Jelly Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 292607 0
Condition category
Condition code
Diet and Nutrition 292920 292920 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, crossover feeding trial that requires pre-screening, 1 baseline visit, and 3 feeding sessions. Data collection will be conducted at the University of South Australia.

The baseline visit (1 hour) entails the measurement of body weight, height, body fat % (BIA method), and self-administered questionnaires on habitual food intake, physical activity levels, eating behaviours (Three-factor Eating Questionnaire). Three preloads will be used during the 3 feeding sessions and they are: 1) milk-based jelly with sucrose (100g low-fat milk, 4.7g gelatine powder, 50g sugar, red food colouring); 2) milk-based jelly with artificial sweetener (100g low-fat milk, 4.7g gelatine powder, 20 (1 tablet = 6mg sucralose) tablets of Splenda (registered trademark) sweetener, red food colouring), and 3) milk-based jelly with artificial sweetener and maltodextrin (100g low-fat milk, 4.7g gelatine powder, 20 tablets (1 tablet = 6mg sucralose) of Splenda (registered trademark) sweetener, 50g maltodextrin, red food colouring). All ingredients are commercially available in the supermarket. Preload (1) contains sweet carbohydrate; preload (2) is sweet without carbohydrate; and preload (3) is artificially sweetened and contains non-sweet carbohydrate. The use of these 3 preloads will enable researchers to contrast the sensory (sweet) effects from the nutrient (carbohydrate) effects in this study.

On the feeding days, participants will arrive at lab (P-108c) in the morning after an overnight fasting of at least 10 hours and have avoided alcohol and strenuous physical activities on the previous day. Upon arrival, participants will be asked to lie down and rest for 30 minutes. After the 30-min rest, baseline resting energy expenditure will be measured for 30 minutes using an indirect calorimeter (TrueMax 2400, Parvomedic Inc.). Following that, participants will be asked to complete an appetite questionnaire (visual analog scales, VAS) before consuming the preload. Participants will be given 15 minutes to consume the preload and 100ml water will be provided with the preload. After the preload, participants will be asked to complete an appetite questionnaire again, plus a questionnaire to assess the palatability and sweetness (VAS) of the preload they just consumed. Next, energy expenditure will be measured for 3 X 30 minute periods, with 2 X 15-min breaks between measurements. Immediately after indirect calorimetry, appetite will be assessed using a VAS questionnaire again. Participants will then be presented with a buffet lunch consists of commercially available foods (Lab P1-38), where they will be instructed to eat until they are comfortably full. Participants will be given 30 minutes to consume their buffet lunch, and they will be asked to complete an appetite questionnaire (VAS) again before they leave. Participants will keep a food diary to record food and beverage intake for the remaining day. Similar protocol will be repeated until all 3 preload conditions are completed, with a washout period of at least 3 days. Each feeding session will take approximately 4.5 hours.
Intervention code [1] 289915 0
Behaviour
Comparator / control treatment
Milk-based jelly sweetened with sucrose
Control group
Active

Outcomes
Primary outcome [1] 292783 0
Energy expenditure and respiratory quotient (RQ) using an indirect calorimetry TrueMax2400, ParvoMedic
Timepoint [1] 292783 0
30min pre-preload ingestion (at rest), and 0-30min, 45-75min and 90-120min after preload ingestion
Primary outcome [2] 292785 0
Appetite via visual analog scales
Timepoint [2] 292785 0
Pre- and post-preload ingestion, and pre- and post-meal challenged after energy expenditure assessment
Primary outcome [3] 292786 0
Food intake measured through self-administered food intake diary with instructions
Timepoint [3] 292786 0
At meal challenge after energy expenditure measurement, and for the remaining day through food record.
Secondary outcome [1] 309676 0
Habitual food intake is assessed using a multi-pass 24-hour dietary recall method
Timepoint [1] 309676 0
At baseline
Secondary outcome [2] 309677 0
Eating behaviour using Three Factor Eating Questionnaire
Timepoint [2] 309677 0
At baseline
Secondary outcome [3] 309678 0
Habitual physical activity using a validated questionnaire, Johansson G & Westerterp KR (2008) Assessment of the physical activity level with two questions: validation with doubly labeled water. Int J Obes 32, 1031-1033.
Timepoint [3] 309678 0
At baseline
Secondary outcome [4] 309679 0
Body weight and body fat percentage using a bio-electrical impedence scale
Timepoint [4] 309679 0
At baseline and before each indirect calorimeter measurement

Eligibility
Key inclusion criteria
- Normal or overweight (BMI 18-35 kgm-2)
- Non-diabetic and no gastrointestinal diseases
- Literate and able to report food intake
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Taking medications that affect metabolism and appetite
- Food intolerance or allergies
- Vegetarian

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 is concealed via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is powered (80%, alpha=0.05) to detect a difference of 250kcal in total daily energy intake based on a mean intake of 2000 kcal/day (standard deviation of 400kcal). This difference is considered clinically important.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2014
Actual
3/07/2014
Date of last participant enrolment
Anticipated
31/01/2016
Actual
25/06/2015
Date of last data collection
Anticipated
Actual
31/07/2015
Sample size
Target
20
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8484 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 289685 0
University
Name [1] 289685 0
University of South Australia
Country [1] 289685 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 288379 0
None
Name [1] 288379 0
None
Address [1] 288379 0
None
Country [1] 288379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291425 0
UniSA's Human Research Ethics Committee
Ethics committee address [1] 291425 0
Ethics committee country [1] 291425 0
Australia
Date submitted for ethics approval [1] 291425 0
Approval date [1] 291425 0
12/06/2014
Ethics approval number [1] 291425 0
0000033058

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 140 140 0 0
/AnzctrAttachments/366811-Information sheet sweet taste Final v2.0.docx

Contacts
Principal investigator
Name 50302 0
Dr Sze Yen Tan
Address 50302 0
University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide, SA 5001
Country 50302 0
Australia
Phone 50302 0
+618 8302 1399
Fax 50302 0
Email 50302 0
[email protected]
Contact person for public queries
Name 50303 0
Sze Yen Tan
Address 50303 0
University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide, SA 5001
Country 50303 0
Australia
Phone 50303 0
+618 8302 1399
Fax 50303 0
Email 50303 0
[email protected]
Contact person for scientific queries
Name 50304 0
Sze Yen Tan
Address 50304 0
University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide, SA 5001
Country 50304 0
Australia
Phone 50304 0
+618 8302 1399
Fax 50304 0
Email 50304 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
EmbaseEnergy expenditure, carbohydrate oxidation and appetitive responses to sucrose or sucralose in humans: A pilot study.2019https://dx.doi.org/10.3390/nu11081782
N.B. These documents automatically identified may not have been verified by the study sponsor.