Yarar-Fisher Ceren, Li Jia, McLain Amie, Gower Barbara, Oster Robert, Morrow Casey
Department of Physical Medicine and Rehabilitation, UAB School of Medicine, 190 Spain Rehabilitation Center, 1717 6th Avenue South, Birmingham, AL, 35233, USA.
Department of Nutrition Sciences, UAB School of Health Professions, 1675 University Blvd., Webb 624C, Birmingham, AL, 35294, USA.
Trials. 2019 Jul 30;20(1):466. doi: 10.1186/s13063-019-3520-3.
Metabolic disorders (e.g., impaired glucose tolerance, insulin resistance, and type 2 diabetes) are more prevalent in people with spinal cord injury (SCI) than able-bodied individuals. Dietary modification is a more cost-effective treatment option than pharmacological therapies for reducing the risk of metabolic dysfunction. Lowering carbohydrate, increasing protein, and maintaining a proper dietary fat intake are expected to induce favorable adaptations in glucose control, body fat distribution, and the composition of the gut microbiome. However, dietary modification has not been rigorously investigated in people with SCI. The purpose of this study is to determine if an 8-week low-carbohydrate/high-protein (LC/HP) dietary intervention will show improvements in clinically important metrics of metabolic function, body composition, the composition of gut bacteria, and quality of life.
METHODS/DESIGN: We intend to recruit 100 participants with chronic traumatic SCI (3 years postinjury, C5-L2, American Spinal Injury Association impairment scale A-D, and aged 18-65 years) and insulin resistance, impaired glucose tolerance or untreated type 2 diabetes and randomly assign them to an 8-week LC/HP dietary intervention group or a control group. The daily LC/HP dietary intervention includes ~ 30% total energy as protein (1.6 g/kg per day) with a carbohydrate-to-protein ratio < 1.5 and fat intake set at ~ 30% of the total energy intake. The control group does not receive any dietary intervention and are continuing with their regular daily diets. Glucose tolerance, insulin sensitivity, β-cell function, body composition, gut microbiome composition, and quality of life measures are assessed at week 1, before starting the LC/HP dietary intervention, and at week 8, after completion of the LC/HP dietary intervention.
New information derived from this project will result in the development of a low-cost, simple, self-administered LC/HP dietary intervention for improving metabolic function in individuals with chronic SCI, improved understanding of the composition of gut bacteria in SCI, and how a LC/HP dietary intervention alters gut bacteria composition. In addition, this project will improve our understanding of the relationship between metabolic function and quality of life in individuals with long-standing SCI.
ClinicalTrials.gov, NCT03207841. Registered on 5 June 2017.
代谢紊乱（如糖耐量受损、胰岛素抵抗和2型糖尿病）在脊髓损伤（SCI）患者中比健全人更为普遍。饮食调整是一种比药物治疗更具成本效益的降低代谢功能障碍风险的治疗选择。降低碳水化合物摄入量、增加蛋白质摄入量并保持适当的膳食脂肪摄入量有望在血糖控制、体脂分布和肠道微生物群组成方面产生有利的适应性变化。然而，饮食调整在SCI患者中尚未得到严格研究。本研究的目的是确定为期8周的低碳水化合物/高蛋白（LC/HP）饮食干预是否会改善代谢功能、身体成分、肠道细菌组成和生活质量等临床重要指标。
方法/设计：我们计划招募100名慢性创伤性SCI患者（受伤3年，损伤平面C5-L2，美国脊髓损伤协会损伤分级A-D级，年龄18-65岁），且患有胰岛素抵抗、糖耐量受损或未经治疗的2型糖尿病，将他们随机分配到为期8周的LC/HP饮食干预组或对照组。每日LC/HP饮食干预包括蛋白质提供约30%的总能量（每天1.6克/千克），碳水化合物与蛋白质的比例<1.5，脂肪摄入量设定为总能量摄入量的约30%。对照组不接受任何饮食干预，继续其日常常规饮食。在开始LC/HP饮食干预前的第1周以及完成LC/HP饮食干预后的第8周，评估糖耐量、胰岛素敏感性、β细胞功能、身体成分、肠道微生物群组成和生活质量指标。
本项目获得的新信息将促成开发一种低成本、简单、可自行实施的LC/HP饮食干预措施，以改善慢性SCI患者的代谢功能，增进对SCI患者肠道细菌组成的了解，以及LC/HP饮食干预如何改变肠道细菌组成。此外，本项目将增进我们对长期SCI患者代谢功能与生活质量之间关系的理解。
ClinicalTrials.gov，NCT03207841。于2017年6月5日注册。
