Nerylee Ann Watson1, Kathryn Ann Dyer2, Jonathan David Buckley3, Grant David Brinkworth4, Alison Mary Coates5, Gaynor Parfitt6, Peter Ranald Charles Howe7, Manny Noakes8, Louise Dye9, Helen Chadwick10, Karen Joy Murphy11. 1. Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia. Electronic address: nerylee.watson@mymail.unisa.edu.au. 2. Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia. Electronic address: Kate.Dyer@unisa.edu.au. 3. Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia. Electronic address: Jon.Buckley@unisa.edu.au. 4. Food and Nutrition, Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, SA 5000, Australia. Electronic address: grant.brinkworth@csiro.au. 5. Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia. Electronic address: Alison.Coates@unisa.edu.au. 6. Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia. Electronic address: Gaynor.Parfitt@unisa.edu.au. 7. Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Peter.Howe@newcastle.edu.au. 8. Food and Nutrition, Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, SA 5000, Australia. Electronic address: manny.noakes@csiro.au. 9. School of Psychology, University of Leeds, Leeds LS2 9JT, United Kingdom. Electronic address: L.Dye@leeds.ac.uk. 10. School of Psychology, University of Leeds, Leeds LS2 9JT, United Kingdom. Electronic address: H.K.Chadwick@leeds.ac.uk. 11. Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia. Electronic address: Karen.Murphy@unisa.edu.au.
Abstract
BACKGROUND:Hypocaloric low-fat diets, high in protein with moderate carbohydrate (HP) can enhance weight loss, improve glycaemic control and improve cardiometabolic health risk factors in type 2 diabetes mellitus (T2DM). However, it is unclear whether the metabolic benefits observed during weight loss are sustained during energy-balance and weight maintenance. Furthermore, there is a lack of evidence regarding the effect of HP diets on food cravings, cognitive function and psychological wellbeing in T2DM, despite carbohydrate food cravings, cognitive impairment and depression being associated with hyperglycaemia. METHODS/ DESIGN:Overweight/obese adults with T2DM were randomised to consume either a HP diet (n=32, ~32% protein, 33% carbohydrate, 30% fat) or a higher-carbohydrate diet (HC, n=29, ~22% protein, 51% carbohydrate, 22% fat) for 24 weeks with 30 min of moderate intensity exercise five days/week for the study duration. There were 2 phases: a 12 week weight loss phase followed by a 12 week weight maintenance phase. Primary outcome was glycaemic control (glycosylated haemoglobin; HbA1c). Secondary outcomes were cardiometabolic risk factors (body composition, fasting blood pressure, blood lipids, glucose, insulin and C-reactive protein), food cravings, cognitive function (memory; psychomotor and executive function and psychological well-being. Outcomes were measured at baseline and the end of each 12-week intervention phase. Data will be analysed as intention-to-treat using linear mixed effects models. CONCLUSION: This study will examine the effects of two dietary interventions on health outcomes in T2DM during weight loss and notably following weight maintenance where there is a paucity of evidence.
RCT Entities:
BACKGROUND: Hypocaloric low-fat diets, high in protein with moderate carbohydrate (HP) can enhance weight loss, improve glycaemic control and improve cardiometabolic health risk factors in type 2 diabetes mellitus (T2DM). However, it is unclear whether the metabolic benefits observed during weight loss are sustained during energy-balance and weight maintenance. Furthermore, there is a lack of evidence regarding the effect of HP diets on food cravings, cognitive function and psychological wellbeing in T2DM, despite carbohydrate food cravings, cognitive impairment and depression being associated with hyperglycaemia. METHODS/ DESIGN: Overweight/obese adults with T2DM were randomised to consume either a HP diet (n=32, ~32% protein, 33% carbohydrate, 30% fat) or a higher-carbohydrate diet (HC, n=29, ~22% protein, 51% carbohydrate, 22% fat) for 24 weeks with 30 min of moderate intensity exercise five days/week for the study duration. There were 2 phases: a 12 week weight loss phase followed by a 12 week weight maintenance phase. Primary outcome was glycaemic control (glycosylated haemoglobin; HbA1c). Secondary outcomes were cardiometabolic risk factors (body composition, fasting blood pressure, blood lipids, glucose, insulin and C-reactive protein), food cravings, cognitive function (memory; psychomotor and executive function and psychological well-being. Outcomes were measured at baseline and the end of each 12-week intervention phase. Data will be analysed as intention-to-treat using linear mixed effects models. CONCLUSION: This study will examine the effects of two dietary interventions on health outcomes in T2DM during weight loss and notably following weight maintenance where there is a paucity of evidence.
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