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.
Completed
- Conditions
- Type 2 diabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12607000394448
- Lead Sponsor
- ational Health and Medical Research Council (NHMRC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Type 2 diabetes, Australian-born.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Primary Outcome: Glycaemic control[Timepoints: at baseline, week 12 and week 24.];Primary Outcome: weight loss[Timepoints: at baseline, week 12 and week 24.];Primary Outcome: Lipids[Timepoints: at baseline, week 12 and week 24.];Primary Outcome: blood pressure[Timepoints: at baseline, week 12 and week 24.]
- Secondary Outcome Measures
Name Time Method 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.<br>Secondary Outcomes: Plasma carotenoids.[At baseline, week 12 and week 24.];Secondary Outcomes: Dietary plant to animal food ratio.<br>[At baseline, week 12 and week 24.]