UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016937 |
|---|---|
| Receipt number | R000019643 |
| Scientific Title | A Study for Effect of Ingesting DHA Containing Capsules to the Sleeping Conditions |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/04/26 17:37:57 |
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Basic information
Public title
A Study for Effect of Ingesting DHA Containing Capsules to the Sleeping Conditions
Acronym
Effect of Ingesting DHA Containing Capsules to the Sleeping Conditions
Scientific Title
A Study for Effect of Ingesting DHA Containing Capsules to the Sleeping Conditions
Scientific Title:Acronym
Effect of Ingesting DHA Containing Capsules to the Sleeping Conditions
Region
| Japan |
Condition
Condition
Effect of DHA Containing Capsules to Improve the Sleep Condition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy of capsules containing DHA on the sleeping conditions by Japanese adult males (aged 30-50 years).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Brain wave measurement(observation period I: 3 days before Week 0 and Week 2; observation period II: 3 days before Week 0 and Week 2)
[2]Pittsburgh Quality of Sleep Index (PSQI-J)(observation period I: Week 0 and Week 2; observation period II: Week 0 and Week 2)
[3]Obstructive Sleep Apnoea (OSA)(observation period I: 3 days before Week 0 to the last day of Week 2; observation period II: 3 days before Week 0 to the last day of Week 2)
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test product (observation period I: 2 weeks)
> Washout (2 weeks)
> Oral ingestion of the control product (observation period II: 2 weeks)
Interventions/Control_2
Oral ingestion of the control product (observation period I: 2 weeks)
> Washout (2 weeks)
> Oral ingestion of the test product (observation period II: 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
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
[1]Japanese males aged 30-50 years
[2]Individuals who are healthy and do not treat any disease
[3]Individuals whose BMI is 18.5-25.0 kg/m^2
[4]Individuals who are not satisfied with sleeping (ex. insomnia, nocturnal awakening, early morning awakening, disrupted sleep)
[5]Individuals who work on daytime of Monday to Friday and have Saturdays and Sundays off
[6]Individuals whose sleeping hours from bedtime to wake-up time is over 4 hours
[7]Individuals whose bedtime and wake-up time is regular and bedtime is before 0 AM
[8]Individuals who sign the consent document after explanation of this study
[9]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals who are a suspected patient, currently, or have treated with sleep apnea syndrome (SAS)
[3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[4]Individuals with serious anemia
[5]Individuals whose observed data of AST (GOT) and ALT (GPT) is over 1.5 times of the standard value
[6]Individuals whose observed data of UA is over 8.5mg/dL
[7]Individuals whose observed data of indexes of lipid-based system is over 2.0 times of the standard value
[8]Individuals whose observed data of HbA1c (NGSP) is over 7.0
[9]Individuals whose observed data of systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
[10]Individuals who are sensitive to test product or other foods, and medical products
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 1 month or will ingest those foods during the test period
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[13]Individuals who is a smoker
[14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[15]Individuals who participated in other clinical studies in the past three months
[16]Individuals who are sensitive to the electrode pad
[17]Individuals judged inappropriate for the study by the principal
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Ono |
Organization
Medical Corporation Wakei-kai Medics Hongo Clinic
Division name
Internal Department
Zip code
Address
2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL
03-6801-9761
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
Address
6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
03-6801-8480
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruha Nichiro Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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
| 2015 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 28 | 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
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019643
