Table_1_Safety and tolerability of a low glycemic load dietary intervention in adults with cystic fibrosis: a pilot study.xlsx

IntroductionTo achieve and maintain adequate weight, people with cystic fibrosis (CF) May often consume energy-dense, nutrient-poor foods high in added sugars and refined carbohydrates; however, little is known about the glycemic and metabolic effects of dietary composition in this patient population. The objective of this pilot study was to investigate the safety and tolerability of a low glycemic load (LGL) diet in adults with CF and abnormal glucose tolerance (AGT).
MethodsTen adults with CF and AGT completed this prospective, open-label pilot study. Mean age was 27.0 ± 2.1 years, 64% were female, and all had pancreatic insufficiency. Each participant followed his/her typical diet for 2 weeks, then transitioned to a LGL diet via meal delivery service for 8 weeks. The primary outcome was change in weight from baseline to study completion, with safety established if no significant decline was noted. Other key safety outcomes included change in hypoglycemia measured by patient report and continuous glucose monitoring (CGM). Exploratory outcomes included changes in other CGM measures, body composition by dual energy X-ray absorptiometry (DXA), and patient reported outcomes.
ResultsThere were no significant changes in weight or in subjectively-reported or objectively-measured hypoglycemia. Favorable non-significant changes were noted in CGM measures of hyperglycemia and glycemic variability, DXA measures of fat mass, and gastrointestinal symptom surveys.
DiscussionA LGL dietary intervention was safe and well tolerated in adults with CF and AGT. These results lay the groundwork for future trials investigating the impact of low-glycemic dietary interventions on metabolic outcomes in the CF population.

引言：为实现并维持适宜体重，囊性纤维化（cystic fibrosis, CF）患者常需摄入高能量、低营养且添加糖与精制碳水化合物含量较高的食物。然而目前针对该患者群体膳食结构对血糖及代谢的影响仍知之甚少。本先导性研究旨在探究低血糖负荷（low glycemic load, LGL）膳食在囊性纤维化合并糖耐量异常（abnormal glucose tolerance, AGT）成年患者中的安全性与耐受性。

方法：本项前瞻性、开放标签先导性研究共纳入10名囊性纤维化合并糖耐量异常的成年受试者。受试者平均年龄为27.0±2.1岁，其中64%为女性，所有受试者均存在胰腺功能不全。每位受试者先遵循自身常规膳食2周，随后通过配餐服务转为低血糖负荷膳食，干预周期为8周。本研究的主要结局指标为从基线至研究结束时的体重变化，若未出现显著体重下降则判定膳食安全性达标。其他关键安全性结局指标包括受试者自我报告与持续血糖监测（continuous glucose monitoring, CGM）所评估的低血糖事件变化情况。探索性结局指标包括其他持续血糖监测指标的变化、双能X线吸收法（dual energy X-ray absorptiometry, DXA）测定的身体成分，以及受试者报告结局指标。

结果：受试者体重、自我报告或客观检测的低血糖事件均未出现显著变化。持续血糖监测所反映的高血糖与血糖变异性、双能X线吸收法测定的脂肪量，以及胃肠道症状问卷评分均呈现出有益的非显著性变化。

讨论：低血糖负荷膳食干预在囊性纤维化合并糖耐量异常的成年患者中安全性良好且耐受性佳。本研究结果为后续探究低血糖膳食干预对囊性纤维化患者代谢结局影响的临床试验奠定了基础。