Evaluation of Safety and efficacy of dietary fiber supplementary combinationin patients with chronic metabolic disorders

Introduction: Intake of dietary fibre (DF) has beneficial effects on the risk factors responsible for development of several chronic diseases like IBS, obesity, colorectal cancer, type 2 diabetes and cardiovascular diseases. Hence this study was conducted with aim to evaluate the safety and efficacy of Fitofy, a soluble dietary supplement in various chronic metabolic disorders and chronic GIT disorders with or without other co-morbidities. Methodology: This prospective, observational, multicentric study was conducted for a period of one year from Jan 22 to Dec 22 including 120 patients. Results and discussion: Statistically significant improvement was seen in various efficacy parameters such asglycaemic control amongst diabetes mellitus patients and lipid profile in dyslipidaemia. Various efficacy parameters for obesity like weight, hunger level and waist circumference showed highly statistically significant fall from baseline. Significant reduction was observed in stool hardness and sensation of incomplete evacuation parameters in patients with constipation. Spontaneous defecation and bowel frequency per week also showed good improvement.Good to excellent safety was observed in 97.19 % of the patient. No adverse event was reported by physician in any patients, A view of good to excellent tolerability was opined by 84.30 % patients. Conclusion: The dietary fiber supplement combination (DFSC) of inulin, partially hydrolysed guar gum, and resistant maltodextrin with proper diet therapy/modifications is found to be safe and effective in causing significant improvements in efficacy parameters of various chronic metabolic disorders like type 2 DM, dyslipidaemia, overweight/obesity, and chronic GI disorders.

引言：膳食纤维（dietary fibre, DF）的摄入可对肠易激综合征（IBS）、肥胖、结直肠癌、2型糖尿病及心血管疾病等多种慢性疾病的致病风险因素产生有益影响。本研究旨在评估可溶性膳食补充剂Fitofy用于伴或不伴其他共病的各类慢性代谢紊乱及慢性胃肠道（gastrointestinal tract, GIT）疾病的安全性与有效性。
方法：本研究为前瞻性、观察性多中心研究，于2022年1月至2022年12月开展，为期一年，共纳入120例患者。
结果与讨论：多项疗效指标均呈现统计学显著改善，其中糖尿病患者的血糖控制水平、血脂异常患者的血脂谱均得到优化。针对肥胖的多项疗效指标（包括体重、饥饿感程度及腰围）较基线水平均出现具有高度统计学意义的下降。便秘患者的粪便硬度及排便不尽感指标均显著降低；每周自发排便次数及排便频率也得到良好改善。97.19%的患者表现为良好至极佳的安全性，医师未报告任何不良事件；84.30%的患者认为该补充剂具有良好至极佳的耐受性。
结论：由菊粉、部分水解瓜尔胶及抗性麦芽糊精组成的膳食纤维复合补充剂（dietary fiber supplement combination, DFSC）联合合理膳食治疗或膳食调整，可安全有效地改善2型糖尿病、血脂异常、超重/肥胖及慢性胃肠道疾病等多种慢性代谢紊乱与慢性胃肠道疾病的疗效相关指标。