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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD002137. doi: 10.1002/14651858.CD002137.pub2
Methods RCT
Participants People with well controlled type I diabetes mellitus (Canada)
CVD risk: moderate
Intervention reduced fat: 18 randomised, 15 analysed
Intervention modified fat: 17 randomised, 15 analysed
Mean years in trial: reduced fat 0.46, modified fat 0.47
% male: reduced fat unclear, modified fat unclear
Age, years: 37.9 (8.1 SD) (not specified by study arm)
Interventions Reduced fat vs Modified fat diet
Reduced fat aims: total fat 27-30%E, SFA ≤10%E, MUFA 10%, CHO 54-57%
Modified fat aims: total fat 37-40%E, SFA ≤10%E, MUFA 20%E, CHO 43-46%E
Reduced fat methods: after initial dietary advice monitored weekly by phone by a dietitian (24 hour food recall). Glycaemia, insulin doses, CHO at meals, hypoglycaemic attacks all self-monitored daily and reported weekly
Modified fat methods: after initial dietary advice monitored weekly by phone by a dietitian (24 hour food recall). Glycaemia, insulin doses, CHO at meals, hypoglycaemic attacks all self-monitored daily and reported weekly
Total fat intake (at 6 months): not stated
Saturated fat intake (at 6 months): not stated
Style: diet advice
Setting: community
Outcomes Stated trial outcomes: Triglycerides and other CVD risk factors
Data available on total mortality? yes (no events)
Cardiovascular mortality? yes (no events)
Events available for combined cardiovascular events: none
Secondary outcomes: cancer deaths (no events) and cancer diagnoses (no events)
Tertiary outcomes: weight; BMI; total, LDL and HDL cholesterol; TGs; systolic and diastolic blood pressure
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk “randomly assigned”
Allocation concealment (selection bias) Unclear risk No details provided
Blinding (performance bias and detection bias)
All outcomes
High risk No details provided, but participants had to make decisions about what they ate
Incomplete outcome data (attrition bias)
All outcomes
High risk Data reported for those who completed
Selective reporting (reporting bias) Unclear risk Unclear
Other bias Low risk
Free of systematic difference in care? Low risk Similar intervention in both groups
Free of dietary differences other than fat? Low risk Focus on fat and CHO intake