Djuric 2009.
Methods | RCT of parallel‐group design | |
Participants | Healthy, non‐obese women aged 25 to 65 years recruited from adverts in community newsletters, health fairs, flyers and employee newsletters in Michigan, US. Women completed 7‐day food diaries. Eligibility criteria: fat intake was at least 23% of calories with no more than 48% from MUFA and fruit and vegetable intake was < 5.5 servings per day. This was to reflect a typical American intake. Women had to have good general health, be current non‐smokers and be in the normal to overweight range (BMI 18 to 30). Exclusion criteria: chronic diseases such as diabetes, autoimmune disease, hypertension, being on medically prescribed diets, taking dietary supplements > 150% RDA, pregnant or lactating and being treated with therapies or supplements that could obscure the results 69 women were randomised; mean age 44 years (range 25 to 59) and mean BMI 24 (19 to 30) |
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Interventions | The intervention was a Greek Mediterranean exchange list diet with exchange goals determined by dieticians at baseline and focused on increasing fruit and vegetable intake and variety and increasing MUFA intake while maintaining the baseline energy intake and total fat intake. The fruit and vegetable goal was 7 to 9 servings/day depending on baseline calorie intake and maintaining baseline energy intake was achieved by substituting fruit and vegetables for other carbohydrates. Variety was achieved using exchange lists. The fat intake goal was PUFA:SFA:MUFA ratio of 1:2:5. This was achieved by reducing usual fat intakes by half using low‐fat food and then adding in olive oil or other high MUFA to the diet to keep energy and total fat intake at baseline levels. Participants were given 3 L of extra‐virgin olive oil at baseline and at 3 months. 7‐day food records were taken at baseline, 3 months and 6 months. Counselling by the dieticians occurred weekly by telephone for the first 3 months and twice weekly thereafter. Face‐to‐face counselling occurred at baseline and 3 months. The intervention period was 6 months. Women were counselled on home eating patterns, restaurant eating, eating at work and special occasions. The comparison group followed their usual diets. They did not receive counselling, but were given the National Cancer Institutes Action guide to healthy eating and written materials on nutritional deficiencies if below 67% RDA. Follow‐up was at 6 months after the end of the intervention period. |
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Outcomes | Total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerol | |
Notes | Body weight increased by 0.24 kg in the control group and decreased by 1.21 kg in the intervention group after the 6‐month intervention period | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not stated. Participants stratified by race and menopausal status prior to randomisation using a block design of 6. |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Differential loss to follow‐up of 23% in the intervention group compared with 3% in the control group. No reasons for loss to follow‐up reported. |
Selective reporting (reporting bias) | Low risk | Reported all outcomes as stated |
Other bias | Unclear risk | Insufficient information to judge |