UMIN-CTR Clinical Trial

Public title

Evaluation of sleep-improving effects of a food

Acronym

Evaluation of sleep-improving effects of a food

Scientific Title

Evaluation of sleep-improving effects of a food

Scientific Title:Acronym

Evaluation of sleep-improving effects of a food

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines sleep-improving effects of a food containing onion extract.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Electroencephalographic(During 5 day intake),
St. Mary's Hospital Sleep Questionnaire(During 5 day intake)

Key secondary outcomes

Salivary amylase(Day before the start,1 day,5 day, 6day),
Sleep diary(From the first day of ingestion of a test food to the last day of the test)

Study type

Interventional

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. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food containing onion extract (3 pills/day;5 days),
wash out period (2 days),
Oral ingestion of the test food not containing onion extract (3 pills/day;5 days).

Interventions/Control_2

Oral ingestion of the test food not containing onion extract (3 pills/day;5 days),
wash out period (2 days),
Oral ingestion of the test food containing onion extract (3 pills/day;5 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

30

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Male and female who don't feel like a good sleep aged 30 to 49 when consent acquisition.
(2)Subjects who have a habit of going to bed before 0 a.m.
(3)Subjects whose Pittsburgh Sleep Quality Index score is over 6.
(4)Subjects who understand the study procedure and agree to participate in the study by giving informed consent prior to the study.

Key exclusion criteria

(1)Subjects using medical products.
(2)Subjects who have a habit of ingestion medicine, health-promoting foods, foods for specified health uses, health foods that may involve this study.
(3)Subjects who have a history of heart failure,liver failure, kidney failure,digestive system disease.
(4)Subjects whose hay fever is under treatment.
(5)Subjects who use pacemaker.
(6)Subjects whose skin is sensitive and develop a rash by adhesive bandage.
(7)Females who are pregnant or lactating, or who could become pregnant or lactating during test period.
(8)Subjects who excessively take alcohol.
(9)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers).
(10)Subjects who have a habit of taking onion over 200g/day.
(11)Subjects who have allergy for medicine and foods.
(12)Subjects whose BMI is over 30.
(13)Subjects who are diagnosed with Sleep apnea syndrome, who are aware of being apena during sleep.
(14)Subjects who cannot use Sleep Scope during the test period.
(15)Subjects who plan to go on a trip with lodging during the test period.
(16)Subjects who cannot give up drinking alcohol during the test period.
(17)Subjects who have a history of sleep disorder.
(18)Subjects using medical products for sleep disorder.
(19)Subjects who plan to participate in other clinical tests.
(20)Subjects who are not eligible for this study for some medical reasons.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Fujiwara Suguru

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name
Middle name
Last name	Makoto Ichinohe

Organization

CPCC Company Limited

Division name

Plan Sales Department

Zip code

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Nisshin Seifun Group Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

Date of disclosure of the study information

2018

Year

02

Month

03

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

01

Month

17

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2018

Year

06

Month

29

Day

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

02

Day

Last modified on

2018

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035544