Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000394448
Ethics application status
Approved
Date submitted
21/06/2007
Date registered
1/08/2007
Date last updated
6/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A dietary study investigating the beneficial effects of a traditional Mediterranean diet on weight, diabetes control and heart disease risk in people with Type 2 diabetes.
Scientific title
A dietary intervention study investigating the impact of a traditional Mediterranean diet on adiposity, metabolic control and coronary risk in people with Type 2 diabetes.
Universal Trial Number (UTN)
Trial acronym
CMIDiT2D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 2184 0
Condition category
Condition code
Metabolic and Endocrine 2279 2279 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised cross-over dietary intervention trial investigating the impact of a traditional Cretan Mediterranean diet on weight change, metabolic control and coronary risk in people with Type 2 diabetes.
Subjects were randomly assigned to consume either the intervention diet ad libitum or their usual diet for 12 weeks and then cross over to the alternate diet for an additional 12 weeks. There was no washout period between the 2 diets. Most of the meals and staple foods for the intervention diet were provided. The types of foods included on the Mediterranean diet included a country style 7 grain bread, vegetable and bean soups, fish soup, vegetarian casseroles and vegetarian baked dishes, stuffed eggplant and stuffed peppers, baked fish, salads with every meal, olives with every meal and extra virgin olive oil in all salads and cooked meals. Dietary adherence was evaluated by monitoring plasma carotenoids and fatty acids, and dietary diaries.
Intervention code [1] 1846 0
Lifestyle
Comparator / control treatment
Usual Diet
Control group
Active

Outcomes
Primary outcome [1] 3168 0
Consumption of the intervention diet resulted in a small but significant improvement in glycaemic control (HbA1c fell from 7.1% to 6.8%; p=0.012) and a trend towards weight loss despite a reported 25% higher energy intake.
Primary Outcome: Glycaemic control
Timepoint [1] 3168 0
Timepoints: at baseline, week 12 and week 24.
Primary outcome [2] 3169 0
Primary Outcome: weight loss
Timepoint [2] 3169 0
Timepoints: at baseline, week 12 and week 24.
Primary outcome [3] 3170 0
Primary Outcome: Lipids
Timepoint [3] 3170 0
Timepoints: at baseline, week 12 and week 24.
Primary outcome [4] 3171 0
Primary Outcome: blood pressure
Timepoint [4] 3171 0
Timepoints: at baseline, week 12 and week 24.
Secondary outcome [1] 5287 0
Consumption of the intervention diet resulted in significant improvements in diet quality; plant to animal food ratio increased from 1.3-5.4; plasma lycopene and lutein/zeaxanthin increased (36% and 25%, respectively) consistent with adherence to the intervention diet supplied: higher intakes of leafy vegetables, tomatoes, garlic and olive oil.
Secondary Outcomes: Plasma carotenoids.
Timepoint [1] 5287 0
At baseline, week 12 and week 24.
Secondary outcome [2] 5288 0
Secondary Outcomes: Dietary plant to animal food ratio.
Timepoint [2] 5288 0
At baseline, week 12 and week 24.

Eligibility
Key inclusion criteria
Type 2 diabetes, Australian-born.
Minimum age
45 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of disabling stroke, cancer not in remission, renal failure, or liver disease; an inability to attend the three hour interview session and participate in the examinations due to incapacitation; or inability to complete the three month dietary intervention due to medical, cultural or religious factors.

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)
Volunteers were randomly allocated to commence with intervention diet OR usual diet and then cross-over to alternate diet after 12 weeks. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using coin-tossing procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2445 0
Government body
Name [1] 2445 0
National Health and Medical Research Council (Grant no.: 974098)
Country [1] 2445 0
Australia
Funding source category [2] 2446 0
Charities/Societies/Foundations
Name [2] 2446 0
Diabetes Australia
Country [2] 2446 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
Country
Australia
Secondary sponsor category [1] 2216 0
Charities/Societies/Foundations
Name [1] 2216 0
Diabetes Australia
Address [1] 2216 0
Country [1] 2216 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4300 0
Deakin University
Ethics committee address [1] 4300 0
Ethics committee country [1] 4300 0
Australia
Date submitted for ethics approval [1] 4300 0
Approval date [1] 4300 0
Ethics approval number [1] 4300 0
EC 31-96

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

Contacts
Principal investigator
Name 27660 0
Address 27660 0
Country 27660 0
Phone 27660 0
Fax 27660 0
Email 27660 0
Contact person for public queries
Name 11035 0
Catherine Itsiopoulos
Address 11035 0
University of Melbourne
Department of Medicine
St Vincent's Hospital
PO Box 2900
29 Regent Street
Fitzroy VIC 3065
Country 11035 0
Australia
Phone 11035 0
+61 3 92882665
Fax 11035 0
+61 3 92882581
Email 11035 0
[email protected]
Contact person for scientific queries
Name 1963 0
Catherine Itsiopoulos
Address 1963 0
University of Melbourne
Department of Medicine
St Vincent's Hospital
PO Box 2900
29 Regent Street
Fitzroy VIC 3065
Country 1963 0
Australia
Phone 1963 0
+61 3 92882665
Fax 1963 0
+61 3 92882581
Email 1963 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.