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. 2009 Jan 21;2009(1):CD006296. doi: 10.1002/14651858.CD006296.pub2

Frost 1994.

Methods Trial Design: RCT 
 Randomisation procedure: random number tables 
 Allocation concealment: not reported 
 Blinding of outcome assessors: not reported 
 Intention to treat analysis: no
Participants Country: UK 
 Setting: Community 
 Number: 60 
 Age: intervention group 54 ± 2 years; comparison group 56 ± 3 years 
 Sex: low‐GI diet group 16 males, 9 females, control group 20 males, 6 females 
 Inclusion criteria: newly diagnosed type 2 diabetes 
 Exclusion criteria: pregnant or lactating women, subjects aged more than 70 years, patients with other endocrine or lipid disorders, had received dietary advice previously, requiring oral hypoglycaemic or insulin therapy, patients where language barrier made instruction difficult 
 Other characteristics: BMI: low‐GI group 30.1± 0.0 kg/m2, control group 29.1 ± 1.3 kg/m2
Interventions Trial intervention: 12 weeks low glycaemic index diet GI= 77 ± 1 
 comparison intervention: 12 weeks standard dietary advice GI= 82 ± 1 
 Duration: 12 weeks
Outcomes Main outcome measure: fructosamine 
 Other outcomes: fasting blood glucose, cholesterol, triglycerides, body weight
Notes Source of funding: British Diabetic Association 
 Drop‐outs: 9, as they failed to complete the study as they did not attend the final appointment (5 in intervention group, 4 in comparison group)
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear