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Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Patients

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rice bran extract group
Control group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rice bran extract group

Control group

Arm Description

This group takes rice bran extract for 8 weeks.

This group takes a placebo for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
serotonin concentration (nM)
Change during 8 weeks
Brain-derived neurotrophic factor concentration (ng/ml)
Change during 8 weeks
salivary cortisol concentration (U/mL)
Change during 8 weeks
dopamine concentration (pg/μL)
Change during 8 weeks

Full Information

First Posted
December 17, 2021
Last Updated
October 13, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05180136
Brief Title
Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Patients
Official Title
Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rice bran extract group
Arm Type
Experimental
Arm Description
This group takes rice bran extract for 8 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group takes a placebo for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Rice bran extract group
Intervention Description
Rice bran extract 1,000 mg/day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Intervention Description
Placebo 1,000 mg/day for 8 weeks
Primary Outcome Measure Information:
Title
The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
Description
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 Outcome Measure Information:
Title
The Korean Version of the Beck-II Depression Inventory (K-BDI II)
Description
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
Title
The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)
Description
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
Title
The Korean version of the Beck Anxiety Inventory (K-BAI)
Description
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
Title
The Korean of the Perceived Stress Scale(K-PSS)
Description
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
Title
serotonin concentration (nM)
Description
Change during 8 weeks
Time Frame
8 weeks
Title
Brain-derived neurotrophic factor concentration (ng/ml)
Description
Change during 8 weeks
Time Frame
8 weeks
Title
salivary cortisol concentration (U/mL)
Description
Change during 8 weeks
Time Frame
8 weeks
Title
dopamine concentration (pg/μL)
Description
Change during 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Yeoup Lee, MD, PhD
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Li Lee
Phone
360-2860
Ext
055
Email
yeri1230@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name & Degree
Ye Li Lee
Phone
360-2869
Ext
055
Email
yeri1230@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Patients

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