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The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.
A previous animal study has indicated that rice bran extract provided inhibition of MAO-B enzyme activity and ROS formation in a corticosterone-induced depression-like animal model. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rice bran extract group | Experimental | This group takes rice bran extract for 8 weeks. |
|
| Control group | Placebo Comparator | This group takes a placebo for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rice bran extract group | Dietary Supplement | Rice bran extract 1,000 mg/day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Korean version of the Hamilton Depression Rating Scale (K-HDRS) | using K-HDRS score. The minimum score was 0 and the maximum score was 50, and higher scores mean a worse outcome. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Korean Version of the Beck-II Depression Inventory (K-BDI II) | using K-BDI II score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome. | 8 weeks |
| The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9) |
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Inclusion Criteria:
- the Korean version of the Hamilton Depression Rating Scale score between 7-24
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409466 | Derived | Huh SY, Lee YL, Kim SH, Lee SY. Efficacy of rice bran extract for alleviating depressive symptoms in adults: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2025 Jul;122(1):112-121. doi: 10.1016/j.ajcnut.2025.05.021. Epub 2025 May 21. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Dietary Supplement | Placebo 1,000 mg/day for 8 weeks |
|
using K-PHQ-9 score. The minimum score was 0 and the maximum score was 27, and higher scores mean a worse outcome. |
| 8 weeks |
| The Korean version of the Beck Anxiety Inventory (K-BAI) | using K-BAI score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome. | 8 weeks |
| The Korean of the Perceived Stress Scale(K-PSS) | using K-PSS score. The minimum score was 0 and the maximum score was 40, and higher scores mean a worse outcome. | 8 weeks |
| serotonin concentration (nM) | Change during 8 weeks | 8 weeks |
| Brain-derived neurotrophic factor concentration (ng/ml) | Change during 8 weeks | 8 weeks |
| salivary cortisol concentration (U/mL) | Change during 8 weeks | 8 weeks |
| dopamine concentration (pg/μL) | Change during 8 weeks | 8 weeks |
| D008722 | Methods |