PMID- 26546883 OWN - NLM STAT- MEDLINE DCOM- 20160914 LR - 20221207 IS - 1559-2030 (Electronic) IS - 1551-7144 (Linking) VI - 45 IP - Pt B DP - 2015 Nov TI - A randomised trial comparing low-fat diets differing in carbohydrate and protein ratio, combined with regular moderate intensity exercise, on glycaemic control, cardiometabolic risk factors, food cravings, cognitive function and psychological wellbeing in adults with type 2 diabetes: Study protocol. PG - 217-225 LID - S1551-7144(15)30112-9 [pii] LID - 10.1016/j.cct.2015.11.001 [doi] AB - 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. CI - Copyright (c) 2015. Published by Elsevier Inc. FAU - Watson, Nerylee Ann AU - Watson NA AD - 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. FAU - Dyer, Kathryn Ann AU - Dyer KA AD - 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. FAU - Buckley, Jonathan David AU - Buckley JD AD - 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. FAU - Brinkworth, Grant David AU - Brinkworth GD AD - Food and Nutrition, Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, SA 5000, Australia. Electronic address: grant.brinkworth@csiro.au. FAU - Coates, Alison Mary AU - Coates AM AD - 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. FAU - Parfitt, Gaynor AU - Parfitt G AD - 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. FAU - Howe, Peter Ranald Charles AU - Howe PRC AD - 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. FAU - Noakes, Manny AU - Noakes M AD - Food and Nutrition, Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, SA 5000, Australia. Electronic address: manny.noakes@csiro.au. FAU - Dye, Louise AU - Dye L AD - School of Psychology, University of Leeds, Leeds LS2 9JT, United Kingdom. Electronic address: L.Dye@leeds.ac.uk. FAU - Chadwick, Helen AU - Chadwick H AD - School of Psychology, University of Leeds, Leeds LS2 9JT, United Kingdom. Electronic address: H.K.Chadwick@leeds.ac.uk. FAU - Murphy, Karen Joy AU - Murphy KJ AD - 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. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20151104 PL - United States TA - Contemp Clin Trials JT - Contemporary clinical trials JID - 101242342 RN - 0 (Blood Glucose) RN - 0 (Dietary Carbohydrates) RN - 0 (Dietary Proteins) RN - 0 (Glycated Hemoglobin A) RN - 0 (Lipids) RN - 9007-41-4 (C-Reactive Protein) SB - IM MH - Blood Glucose MH - Body Weights and Measures MH - C-Reactive Protein MH - Cognition MH - Craving MH - Diabetes Mellitus, Type 2/*epidemiology/psychology/*therapy MH - Diet, Fat-Restricted/*methods MH - Dietary Carbohydrates MH - Dietary Proteins MH - Exercise MH - Glycated Hemoglobin MH - Health Status MH - Humans MH - Lipids/blood MH - Mental Health MH - Obesity/epidemiology/therapy MH - Overweight/*epidemiology/psychology/*therapy MH - Quality of Life MH - Research Design MH - Risk Factors MH - Weight Reduction Programs OTO - NOTNLM OT - Cardiometabolic OT - Cognitive OT - Diabetes OT - Glycemic OT - Protocol OT - Psychological EDAT- 2015/11/08 06:00 MHDA- 2016/09/15 06:00 CRDT- 2015/11/08 06:00 PHST- 2015/07/31 00:00 [received] PHST- 2015/10/27 00:00 [revised] PHST- 2015/11/01 00:00 [accepted] PHST- 2015/11/08 06:00 [entrez] PHST- 2015/11/08 06:00 [pubmed] PHST- 2016/09/15 06:00 [medline] AID - S1551-7144(15)30112-9 [pii] AID - 10.1016/j.cct.2015.11.001 [doi] PST - ppublish SO - Contemp Clin Trials. 2015 Nov;45(Pt B):217-225. doi: 10.1016/j.cct.2015.11.001. Epub 2015 Nov 4.