Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000600448
Ethics application status
Approved
Date submitted
16/10/2007
Date registered
21/11/2007
Date last updated
21/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Eating to Reduce Overweight in people with type 2 diabetes
Scientific title
The role of walnuts in satiety and energy balance in overweight individuals with type 2 diabetes mellitus
Universal Trial Number (UTN)
Trial acronym
HERO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity, type 2 diabetes 2468 0
Condition category
Condition code
Diet and Nutrition 2568 2568 0 0
Obesity
Metabolic and Endocrine 2569 2569 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one year randomised controlled trial to examine the long-term effect of chronic walnut consumption delivering higher polyunsaturated fatty acid (PUFA) intakes in subjects with type 2 diabetes. Participants will be randomised to either a low fat (30 %E) , low saturated fat (10%E) based on 2000kcal/day diet or a similar low fat diet, but inclusive of 30g/day walnuts.
Intervention code [1] 2197 0
Lifestyle
Comparator / control treatment
Low fat diet (standard practice)
Control group
Active

Outcomes
Primary outcome [1] 3474 0
Differences between groups in changes in body weight, percent body fat and visceral fat using bioelectrical impedance, Dual Energy X-ray Absorptiometry (DEXA) and Computed Tomography (CT) scans.
Timepoint [1] 3474 0
Baseline, 3,6,9 and 12 months
Secondary outcome [1] 5794 0
Differences between groups for changes in fasting leptin (by radioimmunoassay), glucose and insulin levels and insulin sensitivity (Homeostasis Model Assessment (HOMA)).
Timepoint [1] 5794 0
Baseline, 3,6,9 and 12 months
Secondary outcome [2] 5795 0
Differences between groups for changes in resting energy expenditure measured using a BodyGem handheld indirect calorimeter.
Timepoint [2] 5795 0
Baseline, 3,6, 9 and 12 months
Secondary outcome [3] 5796 0
Differences between groups for changes in satiety and energy intakes, measured using visual analogue scales and a diet history interview and 3-day food records, respectively.
Timepoint [3] 5796 0
Baseline, 3,6,9 and 12 months

Eligibility
Key inclusion criteria
Type 2 diabetes mellitus (not on insulin), Body Mass Index (BMI) >25 and < 32 kg/m2, waist circumference >102 for men and >94cm for women, and generally well.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major illnesses, food allergies or habits inhibiting the study, illiteracy and inadequate conversational English.

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)
An advertisement was placed in the local media. A screening questionnaire was applied after which subjects attended an information evening where they underwent a diet history assessment and received an accelerometer and physical activity diary.A researcher, independent of the subject interface undertook the randomisation of subjects into diet groups and the code was concealed from the researchers collecting data, as well as from subjects. Allocation involved contacting the holder of the allocation schedule who was off-site or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was performed by using a randomisation table created by a computer software (i.e., computerised sequence generation).
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
15/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 330 0
2522

Funding & Sponsors
Funding source category [1] 2811 0
Commercial sector/Industry
Name [1] 2811 0
California Walnuts Commission
Country [1] 2811 0
United States of America
Primary sponsor type
University
Name
University of Wollongong
Address
Smart Foods Centre
Northfields Avenue
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 2457 0
None
Name [1] 2457 0
Address [1] 2457 0
Country [1] 2457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4736 0
Human Research and Ethics Committee of the University of Wollongong and South East Sydney and Illawarra Health Service
Ethics committee address [1] 4736 0
University of Wollgong
Northfields Avenue
Wollongong NSW 2522
Ethics committee country [1] 4736 0
Australia
Date submitted for ethics approval [1] 4736 0
Approval date [1] 4736 0
01/08/2005
Ethics approval number [1] 4736 0
HE05/145

Summary
Brief summary
This study investigates if the inclusion of a high PUFA food, walnuts, shows favourable trends in body composition in subjects with type 2 diabetes mellitus over the long term (12 months). We assumed that dietary fat-driven changes in body composition take time. Further we examined how the dietary change occurred through food patterns and whether these changes might impact on clinical (glucose homeostasis, lipids), and metabolic (resting energy expenditure and leptin levels) variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28122 0
Address 28122 0
Country 28122 0
Phone 28122 0
Fax 28122 0
Email 28122 0
Contact person for public queries
Name 11279 0
Ms. Cassandra Quick
Address 11279 0
Smart Foods Centre
University of Wollongong
Building 39
Northfields Avenue
Wollongong NSW 2522
Country 11279 0
Australia
Phone 11279 0
+61 2 42215992
Fax 11279 0
+61 2 42214844
Email 11279 0
[email protected]
Contact person for scientific queries
Name 2207 0
Professor Linda Tapsell
Address 2207 0
Smart Foods Centre
University of Wollongong
Building 39
Northfields Avenue
Wollongong NSW 2522
Country 2207 0
Australia
Phone 2207 0
+61 2 42213152
Fax 2207 0
+61 2 42214844
Email 2207 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
SourceTitleYear of PublicationDOI
Dimensions AIIncreased Intake of Dietary Polyunsaturated Fat Does Not Promote Whole Body or Preferential Abdominal Fat Mass Loss in Overweight Adults2011https://doi.org/10.1159/000333433
N.B. These documents automatically identified may not have been verified by the study sponsor.