Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

NCT05180136 | Completed

• 1 other identifier: 02-2021-031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Korean Version of the Beck-II Depression Inventory (K-BDI II)

  8 weeks

• The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)

  8 weeks

• The Korean version of the Beck Anxiety Inventory (K-BAI)

  8 weeks

• The Korean of the Perceived Stress Scale(K-PSS)

  8 weeks

• serotonin concentration (nM)

  8 weeks

Study Arms (2)

Rice bran extract group

EXPERIMENTAL

This group takes rice bran extract for 8 weeks.

Dietary Supplement: Rice bran extract group

Control group

PLACEBO COMPARATOR

This group takes a placebo for 8 weeks.

Dietary Supplement: Control group

Interventions

Rice bran extract group DIETARY_SUPPLEMENT

Rice bran extract 1,000 mg/day for 8 weeks

Rice bran extract group

Control group DIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 8 weeks

Control group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- the Korean version of the Hamilton Depression Rating Scale score between 7-24

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Related Publications (1)

• Huh SY, Lee YL, Kim SH, Lee SY. Efficacy of rice bran extract for alleviating depressive symptoms in adults: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2025 Jul;122(1):112-121. doi: 10.1016/j.ajcnut.2025.05.021. Epub 2025 May 21.

  PMID: 40409466 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: January 20, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)