Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

Pusan National University Yangsan Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Depression

Interventions

Rice bran extract groupDIETARY_SUPPLEMENT

Rice bran extract 1,000 mg/day for 8 weeks

Control groupDIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 8 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

serotonin concentration (nM)

Change during 8 weeks

Time frame: 8 weeks

Brain-derived neurotrophic factor concentration (ng/ml)

Change during 8 weeks

Time frame: 8 weeks

salivary cortisol concentration (U/mL)

Data from ClinicalTrials.gov

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