Unique ID issued by UMIN | UMIN000042200 |
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Receipt number | R000048139 |
Scientific Title | Investigation on the effect of food containing extract of Hemerocallis fulva on brain waves during sleep -Rondomised placebo-controlled crossover study |
Date of disclosure of the study information | 2020/10/21 |
Last modified on | 2021/07/28 17:09:02 |
Investigation on the effect of food containing extract of Hemerocallis fulva on brain waves during sleep
The effect of food containing extract of Hemerocallis fulva on brain waves during sleep
Investigation on the effect of food containing extract of Hemerocallis fulva on brain waves during sleep -Rondomised placebo-controlled crossover study
The effect of food containing extract of Hemerocallis fulva on brain waves during sleep
Japan |
Healthy adults
Adult |
Others
NO
Verification the influence of sleeping time, brain waves during sleeping, QOL, by ingesting two types of food containing Extract of Hemerocallis fulva or placebo for 2 weeks.
Safety,Efficacy
sleep electroencephalogram
*Secondary outcomes
[1]Pittsburgh Sleep Questionnaire (PSQI-J)
[2]OSA sleep questionnaire
[3]SF-36 Acute version
*Safety
[1]Adverse events and side effects
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
No need to know
2
Treatment
Food |
Oral intake of the test food type 1, containing Extract of Hemerocallis fulva : 2weeks
Oral intake of the Placebo food, not containing Extract of Hemerocallis fulva: 2weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
[1]Age 20-65, Not person suffering from a disease, desk worker aware of mild sleep disturbance (eg, tired, poor sleeping, shallow sleep etc.)
[2]Work schedule: daytime, work 5 days a week, closed twice a week
[3]Bedtime and wake-up time are regular, bedtime is before 24 o'clock, sleeping habits generally over 4 hours
[1]Individuals who are Suspected sleep apnea syndrome (SAS) or during treatment and medical history
[2]Individuals Who are Nocturia, benign prostatic hyperplasia, person with overactive bladder, suspected
[3]Those who have an existing medical condition such as liver disease, renal disease, cardiovascular disease, digestive organ disease, respiratory disease, blood system disease, autoimmune disease, endocrine system disease and metabolic disease
[4]Individuals who are medical allergy or serious food allergy
[5]Individuals who are pregnant, those who intend to become pregnant during the test period, those who are breastfeeding
[6]Individuals who are regularly use medicines, quasi-drugs, supplements, etc. relating to stress improvement and sleep improvement
[7]Individuals who excessively take alcohol(expressed in an amounnt of alcohol: over 60g/day)
[8]Individuals judged inappropriate for the study by the principal and research director
20
1st name | Ryuji |
Middle name | |
Last name | Takeda |
KANSAI UNIVERSITY OF WELFARE SCIENCES
Department of Nutritional Scences for Well-being, Fculty of health Sciences for Welfare
582-0026
Asahigaoka 3-11-1, Kashiwara-city, Osaka, 582-0026, Japan
072-978-0088
rtakeda@tamateyama.ac.jp
1st name | Yonamine |
Middle name | |
Last name | Ikuko |
Okinawa TLO Co., Ltd.
Not Division
903-0213
University of the Ryukyus - Industry-academia-government collaboration building 3F
098-895-1701
hito@okinawa-tlo.com
Nahanishi Clinic.
Somnoquest, co., Ltd
Profit organization
Medical corporation Naha Nishikai Ethics Committee
2-1-9 Akamine, Naha, Okinawa, 901-0154, Japan
098-858-5557
hito@okinawa-tlo.com
NO
那覇西クリニック(沖縄県)
2020 | Year | 10 | Month | 21 | Day |
Unpublished
Completed
2020 | Year | 06 | Month | 03 | Day |
2020 | Year | 10 | Month | 21 | Day |
2020 | Year | 10 | Month | 22 | Day |
2021 | Year | 03 | Month | 31 | Day |
2020 | Year | 10 | Month | 21 | Day |
2021 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048139
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