Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Dietary supplement: Rice bran extract group; Dietary supplement: Control group

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang Yeoup Lee, MD, PhD; Phone Number: 055 360-2860; Email: saylee@pnu.edu
• Study Contact Backup: Name: Ye Li Lee; Phone Number: 055 360-2860; Email: yeri1230@gmail.com

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rice bran extract group; This group takes rice bran extract for 8 weeks.	Dietary supplement: Rice bran extract group; Rice bran extract 1,000 mg/day for 8 weeks
Placebo Comparator: Control group; This group takes a placebo for 8 weeks.	Dietary supplement: Control group; Placebo 1,000 mg/day for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 02-2021-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No