Tehran University of Medical Sciences Iranian Journal of Psychiatry 1735-4587 21 4 2026 09 23 477 487 Sasan Amiri Psycosomatic Medicine Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. Seyed-Ali Mostafavi Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Ahmad Ali Noorbala Psycosomatic Medicine Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. Ariana Karkhaneh Yousefi Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Shahin Akhondzadeh Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran. 2026 08 18 2026 09 08 Objective: We aimed to assess the efficacy of saffron versus placebo on binge eating severity, appetite, and body mass index (BMI) in adults diagnosed with binge eating disorder (BED). Method: This was a 12-week randomized, double-blind, placebo-controlled trial with parallel design. We randomized 59 participants with confirmed diagnoses of BED according to DSM-5 criteria to receive either saffron extract (15 mg per capsule twice daily; total daily dose 30 mg; n = 30) or placebo (15 mg starch per capsule twice daily; n = 29). We assessed binge eating episodes (daily diary), appetite (visual analogue scale [VAS]), BMI, and macronutrient intake (3-day food records) before and after the trial. We analyzed the data using the intention-to-treat (ITT) approach and paired t-tests/Wilcoxon tests for within-group changes and independent t-tests/Mann-Whitney U tests for between-group differences. Furthermore, we used analysis of covariance (ANCOVA) with the primary outcome as the dependent variable and key baseline variables as covariates to compare endpoint outcomes between groups. Results: We detected significant reductions in the saffron group compared with the placebo group in binge eating severity (mean difference: −1.16 ± 0.25; P ≤ 0.001; Cohen’s d = −1.30), Appetite VAS scores (−3.34 ± 0.56; P ≤ 0.001; Cohen’s d = −1.76), Calorie intake (−448 ± 113 kcal/day; P ≤ 0.001; Cohen’s d = −1.03), and Fat intake (−21.45 ± 5.10 g/day; P ≤ 0.001; Cohen’s d = −1.09). Furthermore, the saffron group showed a significant decrease in mean difference of BMI (−0.61 ± 0.45 kg/m²; P = 0.006; Cohen’s d = −0.43). ANCOVA results revealed that the adjusted treatment effect was -1.10 (95% CI: -1.60 to -0.60, P < 0.001). Conclusion: Saffron supplementation significantly decreases the core symptoms of BED, reduces appetite and caloric intake, and modestly lowers BMI. Saffron capsules could be considered a safe and efficient supplement for people undergoing BED treatment. https://ijps.tums.ac.ir/index.php/ijps/article/view/4770 https://ijps.tums.ac.ir/index.php/ijps/article/download/4770/1357