UMIN-CTR Clinical Trial

Public title

Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning

Acronym

Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning

Scientific Title

Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning

Scientific Title:Acronym

Effects of Hemerocallis fulva derived component Containing food on Sleep quality for Research concerning

Region

Japan

Condition

N/A (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Ryuji Takeda

Organization

KANSAI UNIVERSITY OF WELFARE SCIENCES

Division name

Department of Nutritional Scences for Well-being, Fculty of health Sciences for Welfare

Zip code

Address

Asahigaoka 3-11-1, Kashiwara-city, Osaka, 582-0026, Japan

TEL

+81-72-978-0088

Email

rtakeda@tamateyama.ac.jp

Name of contact person

1st name
Middle name
Last name	Masaki Matayoshi

Organization

Okinawa TLO Co., Ltd.

Division name

Not Division

Zip code

Address

University of the Ryukyus - Industry-academia-government collaboration building 3F

TEL

098-895-1701

Homepage URL

Email

nemuri@okinawa-tlo.com

Institute

Nahanishi Clinic.

Institute

Department

Personal name

Organization

Okinawa TLO Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Kurei Okinawa Co., Ltd.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

那覇西クリニック（沖縄県）

Date of disclosure of the study information

2019

Year

01

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

11

Month

16

Day

Date of IRB

2018

Year

11

Month

07

Day

Anticipated trial start date

2018

Year

12

Month

24

Day

Last follow-up date

2019

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

18

Day

Last modified on

2020

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040123