ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

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]

Behaviour

Comparator / control treatment

Milk-based jelly sweetened with sucrose

Control group

Active

Outcomes

Primary outcome [1]

Energy expenditure and respiratory quotient (RQ) using an indirect calorimetry TrueMax2400, ParvoMedic

Timepoint [1]

30min pre-preload ingestion (at rest), and 0-30min, 45-75min and 90-120min after preload ingestion

Primary outcome [2]

Appetite via visual analog scales

Timepoint [2]

Pre- and post-preload ingestion, and pre- and post-meal challenged after energy expenditure assessment

Primary outcome [3]

Food intake measured through self-administered food intake diary with instructions

Timepoint [3]

At meal challenge after energy expenditure measurement, and for the remaining day through food record.

Secondary outcome [1]

Habitual food intake is assessed using a multi-pass 24-hour dietary recall method

Timepoint [1]

At baseline

Secondary outcome [2]

Eating behaviour using Three Factor Eating Questionnaire

Timepoint [2]

At baseline

Secondary outcome [3]

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]

At baseline

Secondary outcome [4]

Body weight and body fat percentage using a bio-electrical impedence scale

Timepoint [4]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5001 - Adelaide

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide SA 5001

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UniSA's Human Research Ethics Committee

Ethics committee address [1]

Research and Innovation Services
Mawson Lakes Campus 
University of South Australia 
GPO Box 2471, Adelaide, SA, 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/06/2014

Ethics approval number [1]

0000033058

Summary

Brief summary

I hypothesise that, compared to a milk-based jelly preload sweetened with table sugar, similar preload sweetened with artificial sweetener sucralose reduces postprandial carbohydrate oxidation but does not affect energy expenditure. I further hypothesise that artificially-sweetened preload does not increase hunger sensations, subsequent food intake, and total daily energy intake.

Diet products (sugar free) are widely used as a strategy to reduce energy intake by individuals who continuously monitor their body weight and by overweight individuals who are trying to lose weight. This practice is supported by findings from intervention studies that reported greater weight loss in adults and less weight gain in children when diet beverages were supplemented. However, some observational studies failed to observe the beneficial effects of artificial sweetener use on body weight, or have even reported positive association between body weight and artificial sweetener use. While it is possible that the relationship observed may be explained by reverse-causation (overweight individuals included more diet products to assist weight loss), there is evidence proposing a neurobiological explanation to heightened food intake induced by artificial sweeteners, which has been documented in animal studies. According to this hypothesis, increased appetite and food intake may be due to the infidelity between sweet taste signals (hinting the body of potential carbohydrate intake) and absence of carbohydrate after the ingestion of artificial sweeteners. While this hypothesis may be plausible, this effect has yet to be replicated in humans, where human studies have found no effect of diet beverages on food intake or hunger sensations. However, what remains unknown is whether artificial sweeteners promote appetite and food intake when they are added to foods in forms other than liquid and where sugar is the only energy source.

Trial website

Trial related presentations / publications

Tan SY, Morby M, Chern C, Mattes RD. Does sweet taste stimulation alter energy expenditure and carbohydrate oxidation in humans? Nutrition & Dietetics 2015, 72(S1):65.

Public notes

Attachments [1]

/AnzctrAttachments/366811-Information sheet sweet taste Final v2.0.docx

Contacts

Principal investigator

Name

Dr Sze Yen Tan

Address

University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide, SA 5001

Country

Australia

Phone

+618 8302 1399

Fax

[email protected]

Contact person for public queries

Name

Sze Yen Tan

Address

University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide, SA 5001

Country

Australia

Phone

+618 8302 1399

Fax

[email protected]

Contact person for scientific queries

Name

Sze Yen Tan

Address

University of South Australia
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide, SA 5001

Country

Australia

Phone

+618 8302 1399

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Energy expenditure, carbohydrate oxidation and appetitive responses to sucrose or sucralose in humans: A pilot study.	2019	https://dx.doi.org/10.3390/nu11081782

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically