Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001140943
Ethics application status
Approved
Date submitted
31/10/2011
Date registered
1/11/2011
Date last updated
1/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The DRINKs Study: Beverage Consumption and Health
Scientific title
The effects of soft drink, diet soft drink, fruit juice, and flavoured low-fat milk on serum uric acid and other risk factors for the metabolic syndrome in insulin resistant individuals
Secondary ID [1] 273306 0
Nil
Universal Trial Number (UTN)
Trial acronym
DRINKs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 270783 0
Hyperuricaemia 279065 0
Insulin resistance 279066 0
Condition category
Condition code
Metabolic and Endocrine 270971 270971 0 0
Metabolic disorders
Diet and Nutrition 279236 279236 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be allocated to one of four intervention groups for 8 weeks:

1: Soft drink
2: Diet soft drink
3: 100% Fruit Juice
4: Low-fat, flavoured milk

The volume of each intervention beverage provided to participants will be matched to each individual participant's habitual intakes of sugary beverages determined by four day diet record
Intervention code [1] 269397 0
Treatment: Other
Intervention code [2] 283628 0
Diagnosis / Prognosis
Intervention code [3] 283629 0
Prevention
Comparator / control treatment
Soft drink
Control group
Active

Outcomes
Primary outcome [1] 279634 0
Serum uric acid (urate) measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [1] 279634 0
0 weeks, 4 weeks, 8 weeks
Primary outcome [2] 279635 0
Insulin sensitivity measured by chemiluminescence using Roche blood chemistry analysers
Timepoint [2] 279635 0
0 weeks, 8 weeks
Secondary outcome [1] 294107 0
Anthropometry (weight, height, body mass index, body fat percentage, waist circumference).

Body fat percentage will be measured using bioelectrical impedance analysis (BIA)
Timepoint [1] 294107 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [2] 294598 0
Triglycerides measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [2] 294598 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [3] 294599 0
Lipid profiles (HDL, LDL) measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [3] 294599 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [4] 294600 0
C - Reactive protein measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [4] 294600 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [5] 294601 0
Fasting plasma glucose measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [5] 294601 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [6] 294602 0
Liver enzymes (ALT, AST) measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [6] 294602 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [7] 294603 0
Plasma antioxidant capacity measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [7] 294603 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [8] 294604 0
Serum creatinine measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [8] 294604 0
0 weeks, 4 weeks, 8 weeks
Secondary outcome [9] 294605 0
Free fatty acids measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [9] 294605 0
0 weeks, 4 weeks, 8 weeks

Eligibility
Key inclusion criteria
McAuley score <8.01
Sugary drink consumption >500mL/day
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Established diabetes, gout, liver or kidney disease, or history of other major chronic illnesses
Diagnosed mental disorders.
Taking medications affecting blood pressure, blood lipids, blood glucose or mood/mental states.
Pregnant or lactating.
Intolerance or allergies to milk, fruit or fructose.
Unable to remain in Dunedin for the duration of the intervention period.

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)
Advertising will take place in the local Dunedin community via flyers and word of mouth. Participants who are interested will contact researchers via email or telephone. Participants (in both cases) will be contacted by phone and screened for sugary beverage consumption to meet the study criteria (>500mL/day) and will be explained the study procedures. Participants, if still interested, will attend a screening visit where anthromopetric measurements, a fasting blood sample and a food frequency questionnaire (FFQ) will be taken. Fasting blood will be analysed for fasting plasma insulin and triglycerides and results will be used to generate a McAuley score. Participants who meet eligibility criteria will have a score of <8.01. FFQs will be analysed for sugar content. If daily consumption of sugar from beverage sources is >50g/day (approximately equivalent to 500mL of sugary beverages) participants meet this eligibility criteria. If participants meet both these criteria and are willing to commit to the study they are enrolled. Eligible participants were randomly assigned an intervention group via sealed envelopes containing a computer-generated block randomisation sequence stratified by gender (male or female) and McAuley score (<=7.0 or >7.0). Neither participants nor investigators will be blinded to intervention groups as, given the nature of the intervention, it would be practically impossible to do so.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation stratified by gender and insulin resistance using a sequence of numbers randomly generated using Microsoft Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 3845 0
New Zealand
State/province [1] 3845 0
Otago

Funding & Sponsors
Funding source category [1] 269865 0
Charities/Societies/Foundations
Name [1] 269865 0
Riddet institute CoRE funding
Country [1] 269865 0
New Zealand
Funding source category [2] 269866 0
University
Name [2] 269866 0
University of Otago
Country [2] 269866 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lisa TeMorenga
Address
Room G25, Union Court, University of Otago, 364 Leith Walk, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 268887 0
Individual
Name [1] 268887 0
Professor Jim Mann
Address [1] 268887 0
Union Court, University of Otago, 364 Leith Walk, Dunedin 9016
Country [1] 268887 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271836 0
University of Otago Ethics Committee
Ethics committee address [1] 271836 0
Ethics committee country [1] 271836 0
New Zealand
Date submitted for ethics approval [1] 271836 0
16/04/2011
Approval date [1] 271836 0
Ethics approval number [1] 271836 0
1/11/0086

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

Contacts
Principal investigator
Name 33163 0
Address 33163 0
Country 33163 0
Phone 33163 0
Fax 33163 0
Email 33163 0
Contact person for public queries
Name 16410 0
Dr Lisa TeMorenga
Address 16410 0
Room 25, Union Court, University of Otago, 364 Leith Walk Dunedin 9016
Country 16410 0
New Zealand
Phone 16410 0
+64 3 479 3978
Fax 16410 0
Email 16410 0
[email protected]
Contact person for scientific queries
Name 7338 0
Dr Lisa TeMorenga
Address 7338 0
Room 25, Union Court, University of Otago, 364 Leith Walk Dunedin 9016
Country 7338 0
New Zealand
Phone 7338 0
+64 3 479 3978
Fax 7338 0
Email 7338 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
No additional documents have been identified.