UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study for Effect of Ingesting DHA Containing Capsules to the Sleeping Conditions
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takahiro Ono
Organization	Medical Corporation Wakei-kai Medics Hongo Clinic
Division name	Internal Department
Address	2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL	03-6801-9761
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019643