Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000517370
Ethics application status
Approved
Date submitted
2/09/2008
Date registered
2/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of a whole grain-rich diet on markers of metabolic syndrome
Scientific title
A 14 week randomised study investigating the effect of a diet rich in wholegrain foods on markers of metabolic syndrome.
Secondary ID [1] 658 0
md46a issued by the Commonwealth Scientific Industrial Research Organisation
Universal Trial Number (UTN)
Trial acronym
WG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 3634 0
Condition category
Condition code
Diet and Nutrition 3799 3799 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to 1 of 2 treatments of 6 weeks duration each and crossed over at the end of each 6 weeks to the alternative. The treatments are either test foods (rice, cereal, bread) consumed daily containing either wholegrain or refined flour. Rice (white/brown) is 60gram raw weight per day, cereal is(weeties/cornflakes) 70gram per day, bread (white/wholemeal multigrain) is 6 slices per day. The wholegrain and refined foods will provide 55% of the total energy of the participants diet (based on 8000 kilojoules). Participants will be required to incorporate the test foods into their existing diet by replacing like foods. In this way efforts will be made to keep the diet kilojoule stable and hence participant weight stable.
There is a 2 week washout period between each treatment phase and participants will consume their usual diet for this time.
Intervention code [1] 3347 0
Lifestyle
Comparator / control treatment
Refined flour is the control treatment.
When refined flour is produced commercially, the germ and outer layers of the grain are removed prior to grinding. This flour consists almost entirely of endosperm, for example the floury part of the kernel. Participants will consume 60gm raw weight per day of white rice, 70gm per day of cornflakes, 6 slices of white bread per day.
Control group
Active

Outcomes
Primary outcome [1] 4695 0
Continuous glucose monitoring system for 24-48hrs (CGMS)
Timepoint [1] 4695 0
Week 6 and week 14
Secondary outcome [1] 7914 0
fibrinolytic factors by blood analysis
Timepoint [1] 7914 0
Week 0, week 6, week 8 and week 14
Secondary outcome [2] 7915 0
insulin, glucose, Total Cholesterol, Triglycerides by blood analysis
Timepoint [2] 7915 0
Week 0, week 6 week 8 and week 14

Eligibility
Key inclusion criteria
Weight not greater than 150kg.
Metabolic syndrome (International Diabetes Federation (IDF) 2006 definition: waist circumference >94cm for men and 80cm for women plus 2 of the following: fasting Triglycerides>1.7 mmol/l, High Density Lipoprotein (HDL) cholesterol< 1.03 (male) or 1.29 (female) , blood pressure> 130/85 or on antihypertensive medication, fasting glucose >5.6mmol/L).
Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent.
No abnormality of clinical significance on medical history.
If female, not pregnant or breast feeding.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Coeliac disease or gluten intolerance.
Have Type 1 or 2 Diabetes.
Have proteinuria, a malignancy, or a history of metabolic disease such as liver, kidney, unstable cardiovascular, clinically significant respiratory or gastrointestinal disease that impairs normal functioning, or are pregnant or lactating.
Have high uncontrolled hypertension (resting recumbent blood pressure (BP) >160/100 mmHg).
History of heavy alcohol consumption (> 5 Standard drinks/day).
Currently on a weight reducing diet.
Unable to comprehend or cope with study requirements.

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)
participants are screened for inclusion and exclusion criteria and once deemed eligible are randomly allocated into one of the 2 lifestyle intervention groups. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using the computer software "Clinstat".
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2008
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)

Funding & Sponsors
Funding source category [1] 3812 0
Commercial sector/Industry
Name [1] 3812 0
Cereal Partners
Country [1] 3812 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
Address
Gate 13 Kintore Avenue Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 3299 0
None
Name [1] 3299 0
Address [1] 3299 0
Country [1] 3299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5871 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 5871 0
Gate 13 Kintore Avenue Adelaide SA 5000
Ethics committee country [1] 5871 0
Australia
Date submitted for ethics approval [1] 5871 0
Approval date [1] 5871 0
21/01/2008
Ethics approval number [1] 5871 0
07/39

Summary
Brief summary
A 14 week study investigating whether whole grain rich diets have beneficial effects on the markers of metabolic syndrome compared to diets rich in refined grains. There will be 2 different diets of 6 weeks each duration. Participants will be required to follow one diet for 6 weeks, then a 2 week "Wash out" (normal eating pattern) before following the second diet for 6 weeks. The study will compare the effect of a diet rich in whole grain foods versus a diet rich in refined grain foods on glucose levels and clot breakdown.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28804 0
Address 28804 0
Country 28804 0
Phone 28804 0
Fax 28804 0
Email 28804 0
Contact person for public queries
Name 11961 0
Anne McGuffin
Address 11961 0
CSIRO Human Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 11961 0
Australia
Phone 11961 0
+61 83038988
Fax 11961 0
+61 83038899
Email 11961 0
[email protected]
Contact person for scientific queries
Name 2889 0
Dr Peter Clifton
Address 2889 0
CSIRO Human Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 2889 0
Australia
Phone 2889 0
+61 8303 8826
Fax 2889 0
+61 83038899
Email 2889 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.