Depression
Conditions
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.
Interventions
DIETARY_SUPPLEMENTRice bran extract group
Rice bran extract 1,000 mg/day for 8 weeks
DIETARY_SUPPLEMENTControl group
Placebo 1,000 mg/day for 8 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Korean version of the Hamilton Depression Rating Scale (K-HDRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Korean version of the Patient Health Questionnaire-9 (K-PHQ-9) | 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. |
| The Korean version of the Beck Anxiety Inventory (K-BAI) | 8 weeks | using K-BAI score. The minimum score was 0 and the maximum score was 63, and higher scores mean a worse outcome. |
| The Korean of the Perceived Stress Scale(K-PSS) | 8 weeks | using K-PSS score. The minimum score was 0 and the maximum score was 40, and higher scores mean a worse outcome. |
| The Korean Version of the Beck-II Depression Inventory (K-BDI II) | 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. |
| Brain-derived neurotrophic factor concentration (ng/ml) | 8 weeks | Change during 8 weeks |
| salivary cortisol concentration (U/mL) | 8 weeks | Change during 8 weeks |
| dopamine concentration (pg/μL) | 8 weeks | Change during 8 weeks |
| serotonin concentration (nM) | 8 weeks | Change during 8 weeks |
Countries
South Korea
Outcome results
None listed