UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041586
Receipt number R000043511
Scientific Title Study of the effect of the food containing plant-derived ingredient Y on sleep
Date of disclosure of the study information 2020/08/28
Last modified on 2021/01/08 23:37:29

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Basic information

Public title

Study of the effect of the food containing plant-derived ingredient Y on sleep

Acronym

The effect of the plant-derived ingredient Y on sleep

Scientific Title

Study of the effect of the food containing plant-derived ingredient Y on sleep

Scientific Title:Acronym

The effect of the plant-derived ingredient Y on sleep

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of plant-derived ingredient Y on sleep

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the OSA questionnaire before and after the 1-week treatment period

Key secondary outcomes

Evaluation of
1) the symptoms questionnaires about sleep, fatigue, stress
2) the nocturnal awakening time and sleep efficiency assessed by actigraph
before and after the 1-week treatment period


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of active tablets (containing plant-derived ingredient X) once a day for 1 week;
Washout (2 weeks);
Intake of placebo tablets (not containing plant-derived ingredient X) once a day for 1 week

Interventions/Control_2

Intake of placebo tablets (not containing plant-derived ingredient X) once a day for 1 week;
Washout (2 weeks);
Intake of active tablets (containing plant-derived ingredient X) once a day for 1 week

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

30 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Adults aged from 30 to 49, or 60 to 69
2) Healthy subjects with no serious disorders
3) Subjects who have dissatisfaction with sleep

Key exclusion criteria

1) Having history or presence of serious disorders
2) Presence of disorders about sleep
3) Taking hypnotics or psychotropic drug
4) Planned to who take a health food about sleep or stress
5) Pregnancies and lactations
6) Heavy alcohol drinker (over 60g per day)
7) Habitually taking much coffee (over five cups per day)
8) Food allergy, drug allergy, metal allergy, or any allergy
9) Feeling discomfort while sleeping with wearing activity monitor attached
10) Subjects who herself and/or her family members are working for an advertising agency, investigation and consultant business, and a mass media-related company, the food company, the cosmetics company, the toiletry company, and company in manufacturing and distribution
11) Planned to participate in other clinical study during current study
12) Determined to be unqualified by the physician in charge or the responsible person of the study

Target sample size

72


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Misawa

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

+81-3-5630-7268

Email

misawa.koichi@kao.com


Public contact

Name of contact person

1st name Chika
Middle name
Last name Suzukamo

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

+81-3-5630-7266

Homepage URL


Email

suzukamo.chika@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.co.jp


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

うえのあさがおクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 28 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

71

Results

A significant difference of the primary outcome was observed in healthy adults in their 60s.

Results date posted

2021 Year 01 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy adults

Participant flow

70 participants completed and 68 subjects were incorporated into the analyses

Adverse events

No adverse effect reported

Outcome measures

Sleep quality

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 08 Month 21 Day

Date of IRB

2019 Year 09 Month 11 Day

Anticipated trial start date

2019 Year 10 Month 05 Day

Last follow-up date

2019 Year 12 Month 06 Day

Date of closure to data entry

2019 Year 12 Month 19 Day

Date trial data considered complete

2019 Year 12 Month 28 Day

Date analysis concluded

2020 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 28 Day

Last modified on

2021 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043511


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name