Randomized, double-blind, placebo-controlled study to evaluate the sleep improving effects and safety of rice bran ethanol extract

Not Applicable

Completed

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0001893
• Lead Sponsor: Korea Food Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age : =18 years
2. Subject with poor sleep quality (A score of =5 Pittsburgh Sleep Quality Index (PSQI))
3. Subject who voluntarily agrees to participate and signs in informed consent form

Exclusion Criteria

1. Subject with severe sleep disorders or insomnia
2. Drug addicts or alcoholics
3. Current major illness (heart, kidney, liver, cerebrovascular, gallbladder, cancer etc.)
4. Subject with neurological or psychiatric disorders
5. Subject who takes drugs or dietary supplement that could have effect on sleeping (ex. sedatives, hypnotics, antidepressants, over-the-counter (OTC) sleep aids, and herbal products etc.)
6. Subject who consumed the functional food containing rice bran extract
7. Excessive use of alcohol (=3 drinks/day or =6 drinks/week) and caffeine (=3 caffeinated drinks/day)
8. Subject who participated in other human studies within one month before the first visit
9. Shift work or irregular sleeping habit
10. Trans-meridian travel within 4 weeks prior to the first visit
11. Cognitive impairment
12. Pregnant or lactating women
13. Any condition that the principal investigator believes may put the subject at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep efficiency, sleep latency, and wake after sleep onset assessed by the polysomnography and actigraph.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index(PSQI);Stanford sleepiness scale(SSS);Epworth sleepiness scale(ESS);Questionnaires for assessing stress;Fatigue severity scale(FSS);Analysis of serum cytokines - interleukin 1ß and tumor necrosis factor -a