UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040717 |
|---|---|
| Receipt number | R000046459 |
| Scientific Title | Investigation of the quality pf sleep effects of food containing Extract of Hemerocallis fulva: A randomized double-blind placebo-controlled parallel-group study |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/07/28 17:17:08 |
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Basic information
Public title
Investigation of the quality pf sleep effects of food containing Extract of Hemerocallis fulva: A randomized double-blind placebo-controlled parallel-group study
Acronym
Investigation of the quality pf sleep effects of food containing Extract of Hemerocallis fulva
Scientific Title
Investigation of the quality pf sleep effects of food containing Extract of Hemerocallis fulva: A randomized double-blind placebo-controlled parallel-group study
Scientific Title:Acronym
Investigation of the quality pf sleep effects of food containing Extract of Hemerocallis fulva
Region
| Japan |
Condition
Condition
Healthy Individuals
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 two types of food containing Extract of Hemerocallis fulva or placebo for 2 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Pittsburgh Sleep Questionnaire (PSQI-J)
2) OSA sleep questionnaire
Key secondary outcomes
*Secondary outcomes
[1] Physical condition change diary
[2] Lifestyle questionnaire
*Safety
[1] Adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food type 1, containing Extract of Hemerocallis fulva : 2 weeks
Interventions/Control_2
Oral intake of the test food type 2, containing Extract of Hemerocallis fulva: 2 weeks
Interventions/Control_3
Oral intake of the Placebo food, not containing Extract of Hemerocallis fulva: 2 weeks
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
Key inclusion criteria
[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
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 amount of alcohol: over 60g/day)
[8]Individuals judged inappropriate for the study by the principal and research director
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
KANSAI UNIVERSITY OF WELFARE SCIENCES
Division name
Department of Nutritional Scences for Well-being, Fculty of health Sciences for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara-city, Osaka, 582-0026, Japan
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Ogidoh |
Organization
Okinawa TLO Co., Ltd.
Division name
Not Division
Zip code
903-0213
Address
University of the Ryukyus - Industry-academia-government collaboration building 3F
TEL
098-895-1701
Homepage URL
ogidoh@okinawa-tlo.com
Sponsor or person
Institute
Nahanishi Clinic.
Institute
Department
Personal name
Funding Source
Organization
Somnoquest, co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Naha Nishikai Ethics Committee
Address
098-858-5557
Tel
098-858-5557
ogidoh@okinawa-tlo.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046459
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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