Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Depression

Treatments: Dietary Supplement: Rice bran extract group; Dietary Supplement: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05180136

02-2021-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Rice bran extract group

Experimental group

Description:

This group takes rice bran extract for 8 weeks.

Treatment:

Dietary Supplement: Rice bran extract group

Control group

Placebo Comparator group

Description:

This group takes a placebo for 8 weeks.

Treatment:

Dietary Supplement: Control group