Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000172808
Ethics application status
Approved
Date submitted
3/02/2012
Date registered
7/02/2012
Date last updated
26/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does dietary fructose restriction improve cardio-metabolic health in obesity?
Scientific title
Does dietary fructose restriction improve plasma lipids, satiety hormones and inflammation in obesity?
Secondary ID [1] 279872 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardio-metabolic Health 285685 0
Obesity 285800 0
Condition category
Condition code
Diet and Nutrition 285873 285873 0 0
Obesity
Metabolic and Endocrine 285874 285874 0 0
Diabetes
Inflammatory and Immune System 285890 285890 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned to the intervention diet (fructose restricted diet) which they will consume for 6 weeks. Participants will consume less than 50 gram fructose per day.

At each visit, participants will receive a 30 - 45 minutes consultation with a qualified dietitian. There will be four visits. One at each of the following time points: Baseline, then weeks 6, 10 and 16.

Subjects will be randomly assigned to either the intervention diet (fructose restricted diet) or the control diet (usual diet), which they will consume for 6 weeks. After a 4 week washout period, they will then consume the alternate diet for 6 weeks.
Intervention code [1] 284140 0
Treatment: Other
Intervention code [2] 284194 0
Lifestyle
Intervention code [3] 284195 0
Prevention
Comparator / control treatment
Subjects will be randomly assigned to the control diet (usual diet), which they will consume for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 286382 0
To determine the effect of dietary fructose restriction on:
Blood Lipids
This outcome will be analysed by blood serum assays.
Timepoint [1] 286382 0
At baseline, at 6 weeks, at 10 weeks, at 16 weeks
Primary outcome [2] 286383 0
To determine the effect of dietary fructose restriction on:
Satiety Hormones
This outcome will be analysed by blood serum assays.
Timepoint [2] 286383 0
At baseline, at 6 weeks, at 10 weeks, at 16 weeks.
Primary outcome [3] 286384 0
To determine the effect of dietary fructose restriction on:
Inflammatory Biomarkers & Insulin Resistance
This outcome will be analysed by blood serum assays.
Timepoint [3] 286384 0
At baseline, at 6 weeks, at 10 weeks, at 16 weeks
Secondary outcome [1] 295892 0
NIL
Timepoint [1] 295892 0
NIL

Eligibility
Key inclusion criteria
Aged between 18 – 65 years at initial assessment. Males or female with BMI>30 [BMI = weight (kg)/ height (m)2]
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are currently on cholesterol lowering drugs e.g. Statins
Are diabetic
Pregnancy or lactation
Are currently on anti-inflammatory drugs e.g. NSAIDs
Are currently on fructose/sugar restricted diets
Diagnosed with any gastrointestinal disorders
Are currently on a weight loss program
Undergone any surgical procedures for obesity
Vegan diet

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomised controlled,dietary intervention trial, in a cross-over design. Participants will be recruited by advertisement in newspaper and radio interviews as well as from the HMRI register of volunteers.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants will be conducted by independent researcher using a randomisation table create by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284618 0
Other
Name [1] 284618 0
Hunter Medical Research Institute (HMRI)
Country [1] 284618 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 283535 0
None
Name [1] 283535 0
Address [1] 283535 0
Country [1] 283535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286610 0
The University of Newcastle Human Ethics Committee
Ethics committee address [1] 286610 0
Ethics committee country [1] 286610 0
Australia
Date submitted for ethics approval [1] 286610 0
01/11/2011
Approval date [1] 286610 0
12/01/2012
Ethics approval number [1] 286610 0
H-2011-0336

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

Contacts
Principal investigator
Name 33689 0
Address 33689 0
Country 33689 0
Phone 33689 0
Fax 33689 0
Email 33689 0
Contact person for public queries
Name 16936 0
Faizan Jameel
Address 16936 0
MS305B
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan
NSW 2308
Country 16936 0
Australia
Phone 16936 0
+61 2 4921 5638
Fax 16936 0
+61 2 4921 2028
Email 16936 0
Faizan.Jameel@uon.edu.au
Contact person for scientific queries
Name 7864 0
Professor Manohar Garg
Address 7864 0
MS305C
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan
NSW 2308
Country 7864 0
Australia
Phone 7864 0
+61 2 4921 5647
Fax 7864 0
+61 2 4921 2028
Email 7864 0
Manohar.Garg@newcastle.edu.au

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.