Bajerska 2018.
Methods | RCT of parallel‐group design | |
Participants | 144 centrally obese postmenopausal women recruited in 2014 through advertisements in Poland Inclusion criteria: non‐smoking, postmenopausal women (with absence of menses of over 12 months or serum follicle‐stimulating hormone > 30 IU/mL) with central obesity (waist circumference; WC ≥ 80 cm), plus at least one other criterion of the metabolic syndrome, who wished to lose weight Exclusion criteria: women with type 2 diabetes; monogenic dyslipidaemia; a history of cardiovascular disease; use of hypoglycaemic, hypolipidaemic, anti‐inflammatory or weight loss agents, as well as any drug known to influence liver function; with endocrine disorders or on hormonal replacement therapy. The exclusion criteria also included significant weight change in the 6 months prior to the current study, intolerance or food allergy to key components of the intervention diets and excessive alcohol consumption (> 2 drinks/day). Mean age 60.5 years |
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Interventions | The 2 supervised dietary intervention arms induced a caloric deficit of ˜2.93 MJ/day, based on individual energy requirements calculated from indirect calorimetry and physical activity (PA) adjustment Mediterranean diet group (MED) Followed a food plan designed on the basis of the Mediterranean dietary recommendations released in 2010 by the Mediterranean Diet Foundation. To build this menu, typical Mediterranean food products were used providing approximately 37% energy from total fat, 20% from MUFAs, 9% from PUFAs, 8% from SFAs, 18% from protein and 45% energy from carbohydrates. Olive oil was used in every meal and 5 to 7 nuts were served once a day. Central European diet group (CED) Based on the recommendations of the NCEP and the AHA, and was designed to provide 27% energy from total fat, 10% from MUFAs, 9% from PUFAs, 8% from SFAs, 18% from protein and 55% energy from carbohydrate, with a special emphasis on high levels of dietary fibre derived from food items typical of the central European region: cereals (oatmeal and barley), pulses (peas and beans), vegetables (root vegetables, cruciferous vegetables) and fruits (apples, plums). The proportion of soluble to insoluble dietary fibre in the CED was 35% to 65%; in the MED this was 20% to 80%. Added salt and refined fats, as well as sugar, were excluded from both diets. 14‐day cyclic dietary plans were formulated for both diets. During the entire 16‐week intervention period, study participants picked up packaged main meals (covering ˜35% daily energy requirements) prepared according to dietician’s recipes by a catering company. Others meals were prepared by the study participants themselves, according to the prescribed dietary plan, including recipes and written instructions to facilitate preparation of meals at home. Throughout the intervention, volunteers were advised to maintain their usual level of PA and keep other lifestyle factors unchanged. |
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Outcomes | Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, SBP, DBP | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer program was used to generate the block randomisation sequence (block size 4), using body mass index as the stratification factor |
Allocation concealment (selection bias) | Unclear risk | Randomisation was performed by study staff who had not been involved in selection of the participants |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were blinded to all laboratory data. All study personnel (except the dieticians) were blinded to the dietary allocation of the participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All study personnel (except the dieticians) were blinded to the dietary allocation of the participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5/72 and 9/72 lost to follow‐up in MED and CED groups respectively with reasons provided |
Selective reporting (reporting bias) | Low risk | All outcomes reported as stated |
Other bias | Unclear risk | Insufficient information to judge |