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NCT Number: NCT05180136

Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rice bran extract group

Dietary Supplement

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

Control group

Dietary Supplement

Placebo 1,000 mg/day for 8 weeks

Primary outcomes

  1. The Korean version of the Hamilton Depression Rating Scale (K-HDRS)

    Time frame: 8 weeks

    using K-HDRS score. The minimum score was 0 and the maximum score was 50, and higher scores mean a worse outcome.

Secondary outcomes

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

    Time frame: 8 weeks

    using K-BDI II score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome.

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

    Time frame: 8 weeks

    using K-PHQ-9 score. The minimum score was 0 and the maximum score was 27, and higher scores mean a worse outcome.

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

    Time frame: 8 weeks

    using K-BAI score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome.

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

    Time frame: 8 weeks

    using K-PSS score. The minimum score was 0 and the maximum score was 40, and higher scores mean a worse outcome.

  5. serotonin concentration (nM)

    Time frame: 8 weeks

    Change during 8 weeks

  6. Brain-derived neurotrophic factor concentration (ng/ml)

    Time frame: 8 weeks

    Change during 8 weeks

  7. salivary cortisol concentration (U/mL)

    Time frame: 8 weeks

    Change during 8 weeks

  8. dopamine concentration (pg/μL)

    Time frame: 8 weeks

    Change during 8 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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