Evaluation of the Efficacy of Crocin on Metabolic and Biochemical Indicators and Weight Loss in Obese Patients Undergoing Bariatric Surgery: A Randomized Clinical Trial

Abstract

Background: Bariatric surgery is a primary approach to managing severe obesity; however, patients frequently experience metabolic, nutritional, and psychological complications during the postoperative period. Crocin, the principal bioactive carotenoid in saffron (Crocus sativus L.), has antioxidant, anti-inflammatory, and neuropsychological properties, but its effects in patients undergoing bariatric surgery remain unclear. Objectives: To assess the effects of crocin supplementation on anthropometric measurements, body composition, metabolic and inflammatory markers, sleep-related outcomes, and psychological status in patients with obesity undergoing bariatric surgery. Methods: A total of 74 individuals with obesity who underwent bariatric surgery at two university-affiliated hospitals were randomly enrolled in this double-blind, placebo-controlled study. Using a randomized allocation procedure, participants were assigned in equal numbers to receive either crocin supplementation (15 mg daily; n = 37) or a matching placebo (n = 37) for 90 days after surgery. The primary endpoint was the change in body mass index (BMI) after 90 days. Secondary endpoints included anthropometric measurements, body composition, biochemical and metabolic markers, inflammatory indices, and sleep- and psychological-related endpoints, which were assessed at baseline and at 90 days after the intervention and compared with placebo. Results: Crocin supplementation did not significantly affect most anthropometric indices, glycemic markers, lipid profiles, liver enzymes, renal function, inflammatory markers, or psychological endpoints compared with placebo. However, reductions in fat-free mass (FFM) and soft lean mass (SLM) were significantly attenuated in the crocin group (P = 0.004 and P = 0.002, respectively), with Hodges-Lehmann median differences of −2.20 kg (95% CI, −3.50 to −0.60) and −2.20 kg (95% CI, −3.50 to −0.70), respectively. Crocin supplementation also resulted in a greater reduction in Insomnia Severity Index (ISI) scores (mean between-group difference = 3.30 points; 95% CI, 0.03 to 6.56; Cohen's d = 0.47; P = 0.048) and a greater improvement in global Pittsburgh Sleep Quality Index (PSQI) scores (Hodges-Lehmann median difference = −2.00 points; 95% CI, −4.00 to 0.00; P = 0.015) compared with placebo. Conclusions: In patients undergoing bariatric surgery, 90-day crocin supplementation did not significantly improve most metabolic or anthropometric endpoints; however, it improved sleep quality, reduced insomnia severity, and attenuated lean mass loss.