ACTRN12606000475549.
Trial name or title | High Protein Diets, Weight Loss and Diabetes Study 2007 Or A 12 week randomised parallel trial comparing 2 different high protein weight loss diets on blood cholesterol levels, blood sugar control and on kidney and cognitive function in Type 2 Diabetes and Obesity: http://www.anzctr.org.au/ACTRN12606000475549.aspx |
Methods | Randomised controlled trial, non‐blinding |
Participants | 80 participants with type 2 diabetes mellitus, obesity |
Interventions | Two different high protein weight loss diets (12 week dietary intervention of daily high protein 34%, low dietary cholesterol 230mg, fat 26%, carbohydrate 37% diet for 3 meals per day) |
Outcomes | Primary outcome measures: low density lipoprotein (LDL); high density lipoprotein (HDL); total cholesterol and triglycerides; fasting ApoB; glucose tolerance test (GTT) (0, 2hours); post‐prandial glucose using CGMS (36hr); HbA1C. Secondary outcome measures: nutrient intakes before and during weight loss; plasma folate, homocysteine; cognitive function; satiety profiles; weight loss (including lean and fat loss as assessed by bioelectrical impedance); renal function (urinary urea, plasma creatinine and microalbuminuria); plasma lutein zeaxanthein and other carotenoids. |
Starting date | February 2007 |
Contact information | http://www.anzctr.org.au/ACTRN12606000475549.aspx . 2006 |
Notes | ongoing |