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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026462
Receipt No. R000030086
Scientific Title The effect of intake of milk beverage in the morning on biological rhythm in human -focus on social jetlag and chronotype-
Date of disclosure of the study information 2017/03/09
Last modified on 2018/09/11

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Basic information
Public title The effect of intake of milk beverage in the morning on biological rhythm in human
-focus on social jetlag and chronotype-
Acronym The effect of intake of milk beverage in the morning on biological rhythm in human
Scientific Title The effect of intake of milk beverage in the morning on biological rhythm in human
-focus on social jetlag and chronotype-
Scientific Title:Acronym The effect of intake of milk beverage in the morning on biological rhythm in human
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to examine the effects of milk beverage in the breakfast on biological rhythm in human.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PER3
*We will assess PER3 expression at baseline and post-intervention.
Key secondary outcomes *We will assess below parameters at baseline and post-intervention.
Hair follicle cell: NR1D1,NR1D2,CLOCK,PER1, PER2, CRY1, CRY2, BMAL1, BMAL2
Saliva:melatonin, testosterone, cortisol, chromogranin A, alpha-amylase, immunoglobulin A
Assessment of physical activity and sleep: accelerometer, motionwatch, morningness-eveningness questionnaire, the center for epidemiologic studies depression scale, pittsburgh sleep quality index

Base
Study type Interventional

Study design
Basic design Parallel
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 Prevention
Type of intervention
Food
Interventions/Control_1 Placebo group
Intervention period (The period of beverage ingestion): 6 days
Interventions/Control_2 Milk beverage in the morning
Intervention period (The period of beverage ingestion): 6 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
40 years-old >
Gender Male
Key inclusion criteria To be able to collect to hair follicle cells
Key exclusion criteria 1) Milk allergy
2) To take medicine related to psychotropic, sleeping, steroid
3) Obesity (BMI>35kg/m2) and sleep apnea syndrome
4) High blood pressure (SBP:above140mmHg, and DBP:above 90mmHg)
5) To take medicine related to diabetes and hyperlipidemia
6) The principal investigator or the principal doctor judge the subject as inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigenobu Shibata
Organization Waseda University
Division name Faculty of Science and Engineering
Zip code
Address 2-2 Wakamatsu-cho, Shinjuku, Tokyo, 162-8480, Japan
TEL +81-3-5369-7318
Email shibatas@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Takahashi
Organization Waseda University
Division name Organization for University Research Initiatives
Zip code
Address 2-2 Wakamatsu-cho, Shinjuku, Tokyo, 162-8480, Japan
TEL +81-3-5369-7318
Homepage URL
Email m-takahashi@aoni.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (S)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Meiji Co., Ltd.
Name of secondary funder(s) The joint research funds of Meiji Corporation

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 09 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 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
2017 Year 03 Month 08 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030086

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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