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一项随机试验,比较碳水化合物与蛋白质比例不同的低脂饮食,并结合规律的中等强度运动,对2型糖尿病成年人血糖控制、心血管代谢危险因素、食物渴望、认知功能和心理健康的影响:研究方案。

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.

作者信息

Watson Nerylee Ann, Dyer Kathryn Ann, Buckley Jonathan David, Brinkworth Grant David, Coates Alison Mary, Parfitt Gaynor, Howe Peter Ranald Charles, Noakes Manny, Dye Louise, Chadwick Helen, Murphy Karen Joy

机构信息

Alliance for Research in Exercise, Nutrition and Activity, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.

Food and Nutrition, Commonwealth Scientific and Industrial Research Organisation, PO Box 10041, Adelaide, SA 5000, Australia.

出版信息

Contemp Clin Trials. 2015 Nov;45(Pt B):217-225. doi: 10.1016/j.cct.2015.11.001. Epub 2015 Nov 4.

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.

摘要

背景

低热量低脂饮食,高蛋白且碳水化合物适中(HP),可促进2型糖尿病(T2DM)患者体重减轻、改善血糖控制并降低心血管代谢健康风险因素。然而,尚不清楚体重减轻期间观察到的代谢益处能否在能量平衡和体重维持期间持续存在。此外,尽管碳水化合物食物渴望、认知障碍和抑郁与高血糖有关,但缺乏关于HP饮食对T2DM患者食物渴望、认知功能和心理健康影响的证据。

方法/设计:超重/肥胖的T2DM成年患者被随机分配,在24周内食用HP饮食(n = 32,蛋白质约32%,碳水化合物33%,脂肪30%)或高碳水化合物饮食(HC,n = 29,蛋白质约22%,碳水化合物51%,脂肪22%),研究期间每周5天进行30分钟中等强度运动。有两个阶段:12周的体重减轻阶段,随后是12周的体重维持阶段。主要结局是血糖控制(糖化血红蛋白;HbA1c)。次要结局是心血管代谢风险因素(身体成分、空腹血压、血脂、血糖、胰岛素和C反应蛋白)、食物渴望、认知功能(记忆;精神运动和执行功能)以及心理健康。在基线和每个12周干预阶段结束时测量结局。数据将使用线性混合效应模型按意向性分析。

结论

本研究将探讨两种饮食干预对T2DM患者体重减轻期间以及特别是在缺乏证据的体重维持期健康结局的影响。

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