Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- the Korean version of the Hamilton Depression Rating Scale score between 7-24
排除标准
- •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
研究组 & 干预措施
Rice bran extract group
This group takes rice bran extract for 8 weeks.
干预措施: Rice bran extract group (Dietary Supplement)
Control group
This group takes a placebo for 8 weeks.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
The Korean version of the Hamilton Depression Rating Scale (K-HDRS)
时间窗: 8 weeks
using K-HDRS score. The minimum score was 0 and the maximum score was 50, and higher scores mean a worse outcome.
次要结局
- The Korean version of the Beck Anxiety Inventory (K-BAI)(8 weeks)
- salivary cortisol concentration (U/mL)(8 weeks)
- The Korean Version of the Beck-II Depression Inventory (K-BDI II)(8 weeks)
- 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)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital