Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT05180136
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Study Start: 2022-01-20
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Korean version of the Hamilton Depression Rating Scale (K-HDRS)	8 weeks	using K-HDRS score. The minimum score was 0 and the maximum score was 50, and higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
The Korean of the Perceived Stress Scale(K-PSS)	8 weeks	using K-PSS score. The minimum score was 0 and the maximum score was 40, and higher scores mean a worse outcome.
serotonin concentration (nM)	8 weeks	Change during 8 weeks
The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)	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.
Brain-derived neurotrophic factor concentration (ng/ml)	8 weeks	Change during 8 weeks
dopamine concentration (pg/μL)	8 weeks	Change during 8 weeks
The Korean Version of the Beck-II Depression Inventory (K-BDI II)	8 weeks	using K-BDI II score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome.
The Korean version of the Beck Anxiety Inventory (K-BAI)	8 weeks	using K-BAI score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome.
salivary cortisol concentration (U/mL)	8 weeks	Change during 8 weeks

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of