Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: Rice bran extract group
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - the Korean version of the Hamilton Depression Rating Scale score between 7-24 Exclusion Criteria: No depressive symptom (K-HRSD ≤ 6) or severely depressed (K-HRSD ≥ 25) Those are taking hormone therapy such as estrogen within the past 6 months Those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.) Those with a history of treatment for depression Abnormal liver or renal function (more than twice the normal upper limit of the research institute) Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar) Uncontrolled hypertension (>160/100 mmHg) Uncontrolled thyroid diseases. Those who are taking drugs, functional foods, herbs, etc. that may affect depression Alcohol abuser Allergic reaction to this test food Those who participated in other drug clinical trials within 1 month from the screening date. Severe gastrointestinal symptoms such as heartburn and indigestion Those who are pregnant, lactating, or plan to become pregnant during the clinical trial Those who are judged to be unsuitable by the PI for other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rice bran extract group<br>This group takes rice bran extract for 8 weeks. | Dietary Supplement: Rice bran extract group<br>* Rice bran extract 1,000 mg/day for 8 weeks<br>|
| Placebo Comparator: Control group<br>This group takes a placebo for 8 weeks. | Dietary Supplement: Control group<br>* Placebo 1,000 mg/day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |