UMIN-CTR Clinical Trial

Public title

Effect of ingestion of trial supplement on sleep. A randomized, placebo controlled, double blind, cross-over study

Acronym

Effect of ingestion of trial supplement on sleep

Scientific Title

Effect of ingestion of trial supplement on sleep. A randomized, placebo controlled, double blind, cross-over study

Scientific Title:Acronym

Effect of ingestion of trial supplement on sleep

Region

Japan

Condition

Healthy subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study is aimed to verify improvement effect of trial supplement on sleep using subjective and objective methods.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

OSA sleep inventory MA version

Key secondary outcomes

Sleep electroencephalogram, POMS 2 brief form, visual analogue scale (VAS) for fatigue, VAS for daytime sleepiness

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Trial supplement (4 days) - washout period - placebo (4 days)

Interventions/Control_2

Placebo (4 days) - washout period - trial supplement (4 days)

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) Japanese males and females aged from 20 to less than 65 years old.
2) Subjects who are weekday workers
3) Global score of Pittsburgh Sleep Quality Index-Japanese version is more than 6.
4)Subjects who can understand the detail of this study and decide to attend the study.

Key exclusion criteria

1) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of sleep or fatigue.
2) Subjects with excessive alcohol-drinking behaviors.
3) Subjects who cannot stop drinking alcohol during study period I and II
4) Subjects who are under the medication, counseling, or exercise therapy.
5) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease.
6) Subjects who have under treatment or a history of sleep apnea syndrome or is suspected of sleep apnea syndrome.
7) Night and day shift worker or manual laborer
8) Working days and holidays are irregular
9) Subjects who have mental illness or insomnia.
10) Subjects who will use medicine for Perennial allergic rhinitis in study period.
11) Heavy smoker
12) Subjects having possibilities for emerging allergy related to the study foods.
13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
14) Subjects who have heavy menstrual cramps and premenstrual syndrome.
15) Subjects who are planned to participate in other clinical study
16) Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Yoshitaka Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

Address

13-4 Kodenma-cho, Chuo-ku, Tokyo, Japan

TEL

03-5641-4133

Email

yiwama@well-sleep.jp

Name of contact person

1st name
Middle name
Last name	Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

Address

1-9-7 Shibaura, Minato-ku, Tokyo, Japan

TEL

03-3452-7733

Homepage URL

Email

yoshikawa@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

医療法人財団健康睡眠会　日本橋循環器科クリニック

Date of disclosure of the study information

2016

Year

04

Month

28

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

2016

Year

04

Month

18

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

26

Day

Last modified on

2016

Year

10

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025425