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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001893

Enrollment

Registered

2016-04-21

Start date

2015-11-04

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects were randomly allocated to placebo group or test group. Each group takes placebo or rice bran ethanol extracts for 14 days.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Sleep efficiency, sleep latency, and wake after sleep onset assessed by the polysomnography and actigraph.	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJungi Kim

Seoul Sleep Center

Outcome results