UMIN-CTR Clinical Trial

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
Email	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
Email	ogidoh@okinawa-tlo.com

Sponsor
Institute	Nahanishi Clinic.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046459