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Efficacy of rice bran extract for alleviating depressive symptoms in adults: a randomized, double-blind,
Sung-Young Huh1, Ye Li Lee2, Su Hui Kim3
1Department of Psychiatry, Pusan National University Yangsan Hospital and Department of Psychiatry, Pusan National University School of Medicine, Yangsan, Republic of Korea.
Background:
Preclinical research indicates the potential benefit of rice bran extract supplements (RBS) in improving depressive-like behaviors and symptoms.
Objectives:
We aimed to evaluate the efficacy and safety of an 8-wk administration of RBS in alleviating depressive symptoms among adults with mild-to-moderate symptom severity.
Methods:
This randomized, double-blind, placebo-controlled trial included 100 adults (aged 19-75 y) with scores of 7-24 on the Korean version of the Hamilton Depression Rating Scale (K-HDRS). Participants were randomly assigned to receive 1 g/d of RBS or a placebo for 8 wk. Evaluations at baseline and after 8 wk included mood assessments using K-HDRS, the Korean version of the Beck Depression Inventory-II, the Patient Health Questionnaire-9 (K-PHQ-9), the Beck Anxiety Inventory (K-BAI), and other psychological scales. Biomarker measurements included serum brain-derived neurotrophic factor, serotonin, dopamine, and salivary cortisol.
Results:
In the RBS and placebo groups, 47 and 50 participants, respectively, completed the intervention. At 8 wk, the RBS group exhibited greater reductions in K-HDRS scores compared with the placebo group (P < 0.001), with adjusted differences of -5.73 [95% confidence interval (CI): -7.07, -4.39; intention-to treat analysis (ITT)] and -5.95 [95% CI: -7.33, -4.57, per-protocol analysis (PP)], corresponding to percent changes of -45.1% (ITT) and -46.0% (PP), respectively. A trend toward greater reductions in the percent changes of K-BDI-II and K-BAI scores was observed in the RBS group compared with the placebo group (ITT and PP). Notably, K-PHQ-9 scores were lower in the RBS group than in the placebo group (P = 0.026, PP) after 8 wk of treatment. However, no significant intergroup differences were identified in other questionnaire scores or biomarker measurements. No adverse events were reported.
Conclusions:
RBS may provide a beneficial effect on depressive symptoms of mild-to-moderate severity in adults.
Trial Registration Number:
This study was registered in clinicaltrials.gov with registration number NCT05180136 (https://clinicaltrials.gov/study/NCT05180136).
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