Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180136
• Other study ID #: 02-2021-031
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression

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