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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022069
Receipt No. R000025425
Scientific Title Effect of ingestion of trial supplement on sleep. A randomized, placebo controlled, double blind, cross-over study
Date of disclosure of the study information 2016/04/28
Last modified on 2016/10/26

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Basic information
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
Condition Healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人財団健康睡眠会 日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 28 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
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
Other related information

Management information
Registered date
2016 Year 04 Month 26 Day
Last modified on
2016 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025425

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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