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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05180136
Other study ID # 02-2021-031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date December 31, 2022

Study information

Verified date January 2024
Source Pusan National University Yangsan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Rice bran extract group
Rice bran extract 1,000 mg/day for 8 weeks
Control group
Placebo 1,000 mg/day for 8 weeks

Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeungsangnam-do

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary serotonin concentration (nM) Change during 8 weeks 8 weeks
Secondary Brain-derived neurotrophic factor concentration (ng/ml) Change during 8 weeks 8 weeks
Secondary salivary cortisol concentration (U/mL) Change during 8 weeks 8 weeks
Secondary dopamine concentration (pg/µL) Change during 8 weeks 8 weeks
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