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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035299
Receipt No. R000040123
Official scientific title of the study Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning
Date of disclosure of the study information 2019/01/08
Last modified on 2018/12/22

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Basic information
Official scientific title of the study Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning
Title of the study (Brief title) Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning
Region
Japan

Condition
Condition N/A (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification the influence of sleeping time, brain waves during sleeping, QOL, by ingesting food containing ingredients derived from Hemerocallis fulva derived component for 2 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Sleep stage analysis of sleep EEG
[2]Pittsburgh Sleep Questionnaire (PSQI-J)
[3]OSA sleep questionnaire
Key secondary outcomes *Secondary outcomes
[1]Physical condition change diary
[2]Lifestyle questionnaire

*Safety
[1]Adverse events and side effects
[2]Blood test
[3]body weight
[4]blood pressure
[5]BMI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral intake of the test foods (5 tablets in a day ; 2 weeks)
Interventions/Control_2 Oral intake of the placebo foods (5 tablets in a day ; 2 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria [1]Age 20-60, Not person suffering from a disease, desk worker aware of mild sleep disturbance (eg, tired, poor sleeping, shallow sleep etc.)
[2]Bedtime and wake-up time are regular, bedtime is before 24 o'clock, sleeping habits generally over 4 hours
[3]Work schedule: daytime, work 5 days a week, closed twice a week
[4]BMI:<25
Key exclusion criteria [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

Target sample size 32

Research contact person
Name of lead principal investigator Ryuji Takeda
Organization KANSAI UNIVERSITY OF WELFARE SCIENCES
Division name Department of Nutritional Scences for Well-being, Fculty of health Sciences for Welfare
Address Asahigaoka 3-11-1, Kashiwara-city, Osaka, 582-0026, Japan
TEL +81-72-978-0088
Email rtakeda@tamateyama.ac.jp

Public contact
Name of contact person Masaki Matayoshi
Organization Okinawa TLO Co., Ltd.
Division name Not Division
Address University of the Ryukyus - Industry-academia-government collaboration building 3F
TEL 098-895-1701
Homepage URL
Email nemuri@okinawa-tlo.com

Sponsor
Institute Nahanishi Clinic.
Institute
Department

Funding Source
Organization Kurei Okinawa Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) UNIVERSITY OF THE RYUKYUS (Okinawa)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 那覇西クリニック(沖縄県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 08 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 11 Month 16 Day
Anticipated trial start date
2018 Year 12 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 18 Day
Last modified on
2018 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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