A Retrospective, Observational Study to Assess the Efficacy, Safety, and Tolerability of Dietary Fiber Supplemental Combination in Overweight or Obese Patients

Study Objective To assess the efficacy, safety, and tolerability of dietary fiber supplementation combination (DFSC) in decreasing the bodyweight (BW) and body mass index (BMI) of obese or overweight patients. Methods This was a retrospective, observational, multicentric, prescription event monitoring study. Forty-two overweight to obese individuals consumed DFSC, a combination of inulin, partially hydrolyzed guar gum, and resistant maltodextrin along with dietary and physical activity interventions. The cases had the following diet intake: 45%-55% carbohydrate, 15%-20% protein, and 20%-25% fat, with 15 g visible fat/day and 18-24 g DFSC daily for 12 consecutive weeks with vigorous diet monitoring fortnightly. Results The mean age of the patients was 40.74 years (standard deviation (SD): 12.16). The mean bodyweight and BMI of the patients were 80.63 kg (SD: 14.34) and 32.24 kg/m(2) (SD: 13.98), respectively, at the baseline. At the end of weeks 4, 8, and 12, diet therapy and DFSC showed statistically significant reductions in the mean bodyweight and BMI as follows: 3.03 kg (SD: 01.24) and 1.18 kg/m(2) (SD: 00.52) (p = 0.001), 5.70 kg (SD: 02.21) and 2.31 kg/m(2) (SD: 01.08) (p = 0.001), and 7.82 kg (SD: 03.06) and 3.27 kg/m(2) (SD: 01.86) (p = 0.001), respectively. Healthcare professionals rated diet therapy and DFSC as good to excellent for their efficacy and safety in 97.6% of the cases, and adverse event was not reported in any case with DFSC. Conclusion Dietary fiber supplemental combination with proper diet therapy/modification was found to be safe and effective in causing significant weight reduction in obese or overweight patients. However, a large multicentric study needs to be conducted.