Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- The Korean of the Perceived Stress Scale(K-PSS)(8 weeks)
- serotonin concentration (nM)(8 weeks)
- The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9)(8 weeks)
- Brain-derived neurotrophic factor concentration (ng/ml)(8 weeks)
- dopamine concentration (pg/μL)(8 weeks)
- The Korean version of the Beck Anxiety Inventory (K-BAI)(8 weeks)
- The Korean Version of the Beck-II Depression Inventory (K-BDI II)(8 weeks)
- salivary cortisol concentration (U/mL)(8 weeks)
Investigators
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital