Harvie 2011.
Study characteristics | ||
Methods | Parallel‐arm randomised clinical trial | |
Participants | 107 premenopausal women based in the UK aged between 30 and 45 with a BMI between 24 and 40 kg/m2 Inclusion criteria and exclusion criteria: participants were non‐smokers, not currently dieting or losing weight, with regular menstrual cycles and no evidence of hyperandrogenism or polycystic ovary syndrome, and no oral contraceptive use during the previous 6 months. They did not have high intakes of alcohol (>28 units/week) or phytoestrogens, and were not suffering from diagnosed diabetes, CVD, major psychiatric morbidity or cancer. |
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Interventions |
2‐arm trial Intermittent fasting (n = 45): periodic fasting 2 consecutive days per week consuming 25% of normal caloric intake. Comparator (n = 47): continuous energy restriction |
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Outcomes | Weight change, insulin sensitivity, total cholesterol and serum LDL levels, serum HDL levels, triglycerides, andSBP and D BP. | |
Notes |
Type of paper: full‐text publication Funding: Breast Cancer Campaign, World Cancer Research Fund, Genesis Appeal Manchester UK, Intramural Research Program of the National Institute on Aging of the NIH, The Danish Research Council for Health and Disease, Tanita Europe BV Middlesex UK for provision of Tanita TBF‐300. Author was contacted for raw data to calculate absolute changes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated. |
Allocation concealment (selection bias) | Unclear risk | There was no mention of a method for allocation sequence concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Since this trial was a dietary intervention study, it was not feasible for participants or all study personnel to be blinded to the group assignment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Laboratory personnel were blinded to the sample identity. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Eighteen women withdrew from the study before 6 months (IER=11, CER=7) representing 21% IER and 13% CER subjects (χ2 =1.16, P=0.28). The main reasons for drop out were comparable between the groups: stress (IER=3, CER=2), pregnancy (IER=2, CER=1), change in employment (IER=2, CER=1), problems adhering to the diet (IER=3, CER=3) and personal illness (infected pacemaker, IER=1)." |
Selective reporting (reporting bias) | Low risk | All outcomes pre‐specified in the Methods section were reported in the Results section. |
Other bias | Low risk | Nothing to note. |