Clinical evidence for fat-binding–mediated fecal fat excretion by RODLTM (Red Okra–Diospyros lotus botanical combination) under a prescribed restricted diet: a randomized, double-blind, placebo-controlled trial

Abstract

Preclinical studies have demonstrated that a botanical combination of red okra (Abelmoschus esculentus) and Diospyros lotus (RODL^TM) exerts dual anti-obesity actions by both inhibiting intestinal fat absorption and stimulating adipocyte lipid metabolism. However, its clinical efficacy in promoting fecal fat excretion under controlled dietary conditions has not been validated in humans. A randomized, double-blind, placebo-controlled clinical trial was conducted in 70 healthy adults under a prescribed restricted diet containing 130–150 g/day of fat. Participants were randomly assigned to receive either RODL (N = 34, 1.5 g/day) or placebo (N = 36) for 2 days. Fecal samples were collected at baseline and post-intervention to quantify fecal fat content (mg/g wet and dry weight, and total mass). Blood lipid profiles and free fatty acids were also assessed. Data were analyzed using the full analysis set and per protocol set with appropriate statistical tests. Following 2-day administration, the RODL group showed a significantly greater increase in fecal fat excretion compared to the placebo group, as measured by wet fecal fat (28.65 ± 17.46 mg/g vs. 18.54 ± 11.86 mg/g, P = 0.0034), dry fecal fat (58.39 ± 29.95 mg/g vs. 39.54 ± 21.39 mg/g, P = 0.0025), and total fecal fat mass (3,238 ± 3,636 mg vs. 1,802 ± 1,713 mg, P = 0.0118). The botanical combination of RODL significantly enhances fecal fat excretion under a standardized fat-controlled diet without affecting fecal matrix properties or safety parameters. These findings support its potential and safe fat-sequestering agent for dietary fat management.