NCT05180136

Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Rice bran extract group	Rice bran extract 1,000 mg/day for 8 weeks
DIETARY_SUPPLEMENT	Control group	Placebo 1,000 mg/day for 8 weeks

Timeline

• Start date: 2022-01-20
• Primary completion: 2022-12-30
• Completion: 2022-12-31
• First posted: 2022-01-06
• Last updated: 2024-02-02

Locations

1 site across 1 country: South Korea