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Trial registered on ANZCTR


Registration number
ACTRN12608000151336
Ethics application status
Approved
Date submitted
26/03/2008
Date registered
28/03/2008
Date last updated
20/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Obesity prevention impact of removing caffeine from soft drinks
Scientific title
The effect of removing caffeine from soft drinks on total energy intake and soft drink consumption in young adults.
Secondary ID [1] 283937 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Energy intake in healthy populations 2959 0
Condition category
Condition code
Diet and Nutrition 3099 3099 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caffeinated soft drinks. Subjects will be asked to consume a prepared soft drink containing 130mg/L (the same amount present in popular cola beverages). During the first 2 weeks of the study they will be asked to consume 600mls per day, for the following 4 weeks of the study, they will be asked to consume as much or as little of the drink as they like and record the amount consumed in a daily log book.
Intervention code [1] 2692 0
Prevention
Comparator / control treatment
Non-caffeinated soft drink. Subjects will be asked to consume a prepared soft drink, identical to the intervention exposure drink expect for the absence of caffeine. During the first 2 weeks of the study they will be asked to consume 600mls per day, for the following 4 weeks of the study, they will be asked to consume as much or as little of the drink as they like and record the amount consumed in a daily log book.
Control group
Active

Outcomes
Primary outcome [1] 3988 0
Energy intake as assessed using 4 day food record and nutrient analysis using Foodworks Pro 2005 (Xyris software QLD).
Timepoint [1] 3988 0
Average energy, intake assessed over 4 days during week 0, will be compared with average energy intake assessed over 4 days during week 6.
Primary outcome [2] 3989 0
Soft drink consumption will be recorded daily using a daily log book.
Timepoint [2] 3989 0
Soft drink intake will be measured daily and the data will be condensed into average weekly consumption for analysis.
Secondary outcome [1] 6707 0
Body weight (kg)
Timepoint [1] 6707 0
Body weight will be measured on two occasions, week 0 and week 6.
Secondary outcome [2] 6711 0
Beverage liking determined using a 9 point Leichart scale ranging from 'like extremely' to 'dislike extremely'.
Timepoint [2] 6711 0
Beverage liking will be measured at week 0 and will be compared with beverage liking measured during week 6.

Eligibility
Key inclusion criteria
Aged between 18-30yrs.
Not pregnant or lactating.
Currently consume sugar sweetened, caffeine containing soft drinks.
Weight stable (no change in body weight in past 6 mths greater than +/- 2kg)
Minimum age
18 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Do not currently consume sugar sweetened caffeinated beverages

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)
The person responsible for determining eligibility of subject will be onsite and will be responsible for the daily operation of the intervention program. They will allocate subjects to either group A or B using a computer generated allocation system (Minim by Stephen Evans, Simon Day and Patrick Royston) following subject consenting to take part in the study. The person allocating subjects and responsible for the daily management of the trial will not be aware which beverage has been assigned to group A or group B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence in which the subjects will be randomised will be Dynamic allocation by minimisation, with sex being the minimisation variable. This will be achieved using the Minim program by Stephen Evans, Simon Day and Patrick Royston available from http://www-users.york.ac.uk/~mb55/guide/minim.htm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
SPSS Version 21.0 software (IBM SPSS) was used for the statistical analysis of the data.
Two-way between groups ANOVA.
Pearson’s product-moment coefficients correlations used for exploring the relationship between average SSB consumption, liking of SSB, BMI, and dietary intake.

The power calculation is based on an estimated effect size of 150ml/day soft drink consumption, which is the observed reduction in the UK trial in 7-11 year olds from an educational program. (James et al BMJ 2004;328:1237) The observed variance in sugar sweetened beverage consumption in a large nationally representative sample of American 18 year olds is 310mls/day with an average intake of 327ml/day.(Striegel-Moore J Pediatr 2006;148:183-7) Among Australian youth who consume soft drinks (akin to the subjects in the study), the mean intake is 480mls/day. Therefore 100 subjects are needed to complete this study to give an 80% chance of seeing a difference in intake between conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 800 0
3125

Funding & Sponsors
Funding source category [1] 3216 0
Charities/Societies/Foundations
Name [1] 3216 0
Diabetes Australia Research Trust
Address [1] 3216 0
5th Floor, 39 London Circuit
Canberra City ACT 2600

GPO Box 3156
Canberra 2601
Australia
Country [1] 3216 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 2883 0
None
Name [1] 2883 0
Address [1] 2883 0
Country [1] 2883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5201 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 5201 0
Research Services
Deakin University
221 Burwood Highway
Burwood VIC 3125
Ethics committee country [1] 5201 0
Australia
Date submitted for ethics approval [1] 5201 0
Approval date [1] 5201 0
13/03/2007
Ethics approval number [1] 5201 0
EC 17-2007

Summary
Brief summary
This research program will test the hypotheses that removing caffeine from soft drinks will significantly decrease liking of and energy intake from these products and that this reduction in energy intake is sufficient to reduce average body weight in the Australian population.

This project has two key aims:
1. To determine if the removal of caffeine from soft drinks results in a decreased consumption of these beverages.
2. To use these results to model the effect of caffeine removal from soft drinks on total energy intake and body weight of the Australian Population.
Trial website
Trial related presentations / publications
Conference presentation: ICO Stockholm 2010 Caffeine increases consumption of sugar sweetened beverages Riddell, LJ1, Keast, RSJ1, Swinburn, B1
Published: Obesity Reviews July 2010 vol 11, issue S1 pg 297
Public notes

Contacts
Principal investigator
Name 28463 0
A/Prof Lynn Riddell
Address 28463 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 28463 0
Australia
Phone 28463 0
+ 61 3 9251 7270
Fax 28463 0
Email 28463 0
lynn.riddell@deakin.edu.au
Contact person for public queries
Name 11620 0
Prof Russell Keast
Address 11620 0
School of Exercise and Nutrition Sciences Deakin University 221 Burwood Highway Melbourne VIC 3125 Australia.
Country 11620 0
Australia
Phone 11620 0
+61 3 9244 6944
Fax 11620 0
+61 3 9244 6640
Email 11620 0
russell.keast@deakin.edu.au
Contact person for scientific queries
Name 2548 0
Prof Russell Keast
Address 2548 0
School of Exercise and Nutrition Sciences Deakin University 221 Burwood Highway Melbourne VIC 3125 Australia.
Country 2548 0
Australia
Phone 2548 0
+61 3 9244 6944
Fax 2548 0
+61 3 9244 6640
Email 2548 0
russell.keast@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary