Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000874819
Ethics application status
Approved
Date submitted
16/08/2012
Date registered
17/08/2012
Date last updated
23/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The FRUIT Study: Fruit – Relationships with Urate and Insulin resistance Trial
Scientific title
A randomised, controlled dietary intervention comparing the effects of fruit consumption to those of soft drink consumption on serum uric acid and other risk factors for the metabolic syndrome in overweight adults
Secondary ID [1] 280995 0
Nil
Universal Trial Number (UTN)
Trial acronym
FRUIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperuricaemia 287124 0
Insulin resistance 287125 0
Metabolic Syndrome 287126 0
Condition category
Condition code
Diet and Nutrition 287444 287444 0 0
Obesity
Metabolic and Endocrine 287445 287445 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will participate in the acute crossover intervention. Once this is completed each participant will then be randomised to one of two intervention groups in a long-term parallel intervention trial, to be commenced immediately:

Acute crossover intervention: On day one participants will attend a clinic where they will be randomly assigned to consume either 600 ml of sugar-sweetened soft drink (600mL) or fruit (3 pieces) after an overnight fast. Between 2 and 5 days later (depending on the participant's availability) they will receive the other treatment.

Long-term parallel intervention: Each participant will be randomly allocated to consume an equivalent amount (isocaloric, equal fructose) of sugar-sweetened soft drink (1 L, provided by the trial investigators) or fruit (5 pieces, provided by the trial investigators) each day for 4 weeks
Intervention code [1] 285445 0
Treatment: Other
Comparator / control treatment
Sugar-sweetened soft drink
Control group
Active

Outcomes
Primary outcome [1] 287710 0
Serum uric acid (urate) measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [1] 287710 0
0 weeks, 4 weeks
Primary outcome [2] 287711 0
Insulin sensitivity measured by chemiluminescence using Roche blood chemistry analysers
Timepoint [2] 287711 0
0 weeks, 4 weeks
Secondary outcome [1] 298670 0
Triglycerides measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [1] 298670 0
0 weeks, 4 weeks
Secondary outcome [2] 298671 0
Lipid profiles (HDL, LDL) measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [2] 298671 0
0 weeks, 4 weeks
Secondary outcome [3] 298672 0
C - Reactive protein measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [3] 298672 0
0 weeks, 4 weeks
Secondary outcome [4] 298673 0
Fasting plasma glucose measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [4] 298673 0
0 weeks, 4 weeks
Secondary outcome [5] 298674 0
Plasma antioxidant capacity measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [5] 298674 0
0 weeks, 4 weeks
Secondary outcome [6] 298675 0
Liver enzymes (ALT, AST) measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [6] 298675 0
0 weeks, 4 weeks
Secondary outcome [7] 298676 0
Serum creatinine measured by fasting serum assay using Roche blood chemistry analysers
Timepoint [7] 298676 0
0 weeks, 4 weeks
Secondary outcome [8] 298678 0
Anthropometry (weight, height, body mass index, body fat percentage, waist circumference). Body fat percentage will be measured using bioelectrical impedance analysis (BIA)
Timepoint [8] 298678 0
0 weeks, 4 weeks

Eligibility
Key inclusion criteria
Overweight but otherwise apparently healthy adults (Body Mass Index (BMI) over or equal to 28)
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Established diabetes, liver or kidney disease, gout or a history of other major chronic illnesses; diagnosed mental disorders; current use of medications affecting blood pressure, blood lipids, blood glucose or mood/mental state; currently pregnant or breastfeeding; intolerance to fruit or fructose; unable to remain in Dunedin, NZ 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 material placed in local Dunedin newspapers, Facebook, University of Otago and Dunedin community notices, and Student Job Search will state that we seek approximately 40 volunteers who are interested in seeing what effects sugary drink and fruit consumption have on their health risks. Volunteers responding to advertisements will be invited to attend a screening appointment at the University of Otago Department of Human Nutrition clinic to establish eligibility to enter the study and collect baseline information. At the appointment the study protocol will be explained in detail and written consent will be obtained before proceeding further. Consenting volunteers who meet the inclusion criteria will be randomized to one of two treatment groups: 1) sugar-sweetened soft drink group, and 2) fruit group. Randomization will be undertaken by a third party away from the Human Nutrition department and will be stratified by sex. 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 randomization stratified by sex 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
Parallel for long-term (randomized) sugar-sweetened soft drink/fruit intake; Crossover for acute intake
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4466 0
New Zealand
State/province [1] 4466 0

Funding & Sponsors
Funding source category [1] 285780 0
University
Name [1] 285780 0
University of Otago Research Grant
Country [1] 285780 0
New Zealand
Funding source category [2] 285824 0
Other Collaborative groups
Name [2] 285824 0
Riddet Institute
Country [2] 285824 0
New Zealand
Primary sponsor type
Individual
Name
Professor Jim Mann
Address
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 284603 0
Individual
Name [1] 284603 0
Dr Lisa TeMorenga
Address [1] 284603 0
Room 25, Union Court, 85 Union Pl West, Dunedin, University of Otago
Country [1] 284603 0
New Zealand
Secondary sponsor category [2] 284604 0
Individual
Name [2] 284604 0
Ms Simonette Mallard
Address [2] 284604 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin, 9054
Country [2] 284604 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287791 0
University of Otago Human Ethics Committee
Ethics committee address [1] 287791 0
Ethics committee country [1] 287791 0
New Zealand
Date submitted for ethics approval [1] 287791 0
09/07/2012
Approval date [1] 287791 0
23/07/2012
Ethics approval number [1] 287791 0
1/12/0197

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

Contacts
Principal investigator
Name 34554 0
Address 34554 0
Country 34554 0
Phone 34554 0
Fax 34554 0
Email 34554 0
Contact person for public queries
Name 17801 0
Dr Lisa TeMorenga
Address 17801 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 17801 0
New Zealand
Phone 17801 0
+64 3 479 3978
Fax 17801 0
+64 3 479 7958
Email 17801 0
[email protected]
Contact person for scientific queries
Name 8729 0
Dr Lisa TeMorenga
Address 8729 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 8729 0
New Zealand
Phone 8729 0
+64 3 479 3978
Fax 8729 0
+64 3 479 7958
Email 8729 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.