Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000106033
Ethics application status
Approved
Date submitted
28/01/2010
Date registered
2/02/2010
Date last updated
2/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The ICE Tea Study: Dietary compensation capabilities in individuals resistant to obesity (expenders) and susceptible to obesity (conservers)
Scientific title
An 8 week randomised, placebo-controlled, double-blind parallel dietary intervention to compare the effects of consuming additional calories on the dietary compensation patterns of individuals who maintain a healthy body weight with relative ease (expenders) and those who struggle to maintain a healthy body weight (conservers).
Secondary ID [1] 1364 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 256686 0
Condition category
Condition code
Diet and Nutrition 256839 256839 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, placebo-controlled, double blind parallel intervention. The study will be carried out to assess the effect of consuming additional calories of the dietary compensation capabilities on individuals who maintain a healthy body weight with relative ease (expenders) and individuals who struggle to maintain a healthy body weight (conservers). Initial respondents will be screened using a pre-tested tool to identify expenders (at least 60) and conservers (at least 60). Participants will then be randomly assigned to receive either 600ml of a sugar-sweetened beverage (1000kJ) or 600ml of a non-caloric beverage per day, for a period of 8 weeks.
Intervention code [1] 255914 0
Lifestyle
Comparator / control treatment
The control group (30 expenders, 30 conservers) will consume 600ml of a non-caloric beverage per day for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 257708 0
Body weight. This will be measured using bioelectrical impedance analysis.
Timepoint [1] 257708 0
At baseline and 8 weeks after intervention commencement.
Secondary outcome [1] 263053 0
Body composition. This will be measured by dual energy x-ray absorptiometry.
Timepoint [1] 263053 0
At baseline and 8 weeks after intervention commencement.
Secondary outcome [2] 263054 0
Blood cholesterol levels. Plasma total and high density lipoprotein cholesterol, and plasma triacylglycerol will be measured by enzymatic methods using a Cobas Mira Plus analyser. Plasma low density lipoprotein cholesterol concentration will be calculated by the Friedewald formula (Friedewald et al., 1972).
Timepoint [2] 263054 0
At baseline and 8 weeks after intervention commencement.

Eligibility
Key inclusion criteria
The inclusion criteria are healthy males (aged 20-55 yrs) and females (aged 20-45 yrs) who are identified as expenders or conservers by the study screening questionnaire.
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who are identified as ineligible by the screening questionnaire. People with a chronic disease such as cancer, heart disease, or diabetes. People with a medical condition that may affect their metabolic rate eg thyroid dysfunction. People with phenylketonuria (as the non-caloric beverage contains phenylalanine). Smokers and post-menopausal females.

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. Allocation will be performed by the statistician who will have no involvement in the enrollment process and is located in another building. This statistician will generate group allocation codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated using random sequences of the four groups generated using SAS 9.1.3. The groups will be balanced using 2 strata constructed using sex (M/F). Allocation will be conducted by the 'off-site' statistician within each strata.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
15/02/2010
Actual
15/02/2010
Date of last participant enrolment
Anticipated
5/07/2010
Actual
2/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2443 0
New Zealand
State/province [1] 2443 0
Otago

Funding & Sponsors
Funding source category [1] 256418 0
Charities/Societies/Foundations
Name [1] 256418 0
The Otago Medical Research Foundation, Laurenson Award
Country [1] 256418 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 255720 0
None
Name [1] 255720 0
Address [1] 255720 0
Country [1] 255720 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258468 0
University of Otago Human Ethics Committee
Ethics committee address [1] 258468 0
Ethics committee country [1] 258468 0
New Zealand
Date submitted for ethics approval [1] 258468 0
Approval date [1] 258468 0
12/01/2010
Ethics approval number [1] 258468 0
Reference Number 09/206

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

Contacts
Principal investigator
Name 30770 0
Mrs Rebecca Cooke
Address 30770 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9054
Country 30770 0
New Zealand
Phone 30770 0
+64 3 4797518
Fax 30770 0
+64 3 4797958
Email 30770 0
[email protected]
Contact person for public queries
Name 14017 0
Rebecca Cooke
Address 14017 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 14017 0
New Zealand
Phone 14017 0
+64 3 4797518
Fax 14017 0
+64 3 4797958
Email 14017 0
[email protected]
Contact person for scientific queries
Name 4945 0
Rebecca Cooke
Address 4945 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 4945 0
New Zealand
Phone 4945 0
+64 3 4797518
Fax 4945 0
+64 3 4797958
Email 4945 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.