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.