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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041223
Receipt No. R000047045
Scientific Title Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/27

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Basic information
Public title Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Acronym Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Scientific Title Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Scientific Title:Acronym Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test whether dietary habits are actually improved by taking a variety of food products based on Chrono Nutrition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of Blood Glucose level accompany eating
Key secondary outcomes Subjective and Objective sleep quality

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subjects are attached Free Style Libre for monitoring brood glucose level.At the same time, the subjects are attached Fitbit for monitoring sleep quality. (2 weeks)

1) Eat test meal as asnacks.
Interventions/Control_2 2) Eat glucose as asnacks.
Interventions/Control_3 3) Eat test meal after dinner.
Interventions/Control_4 4) Do not eat between snacks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
19 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Healthy adults over 19 years of age
2.A subject who related of a school in Aikoku Gakuen Junior College
3.The subject who provided written consent for participation
Key exclusion criteria 1.The subject that cannot cooperate in response to explanation of this examination.
2.The Subject more than BMI 30.
3.The subject whose supervisors judged participation to be inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuko
Middle name
Last name Hirao
Organization Aikoku Gakuen Junior College
Division name Department of Home Economics
Zip code 133-8585
Address 5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL 03-5668-7260
Email hirao@aikoku-jc.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Furutani
Organization Aikoku Gakuen Junior College
Division name Department of Home Economics
Zip code 133-8585
Address 5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL 03-5668-7260
Homepage URL
Email a.furutani@kurenai.waseda.jo

Sponsor
Institute Aikoku Gakuen Junior College
Institute
Department

Funding Source
Organization Calbee, Inc.
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 Aikoku Gakuen Junior College
Address 5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
Tel 03-5668-7260
Email aioffice@aikoku-jc.ac.jp

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
2020 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 21 Day
Date of IRB
2020 Year 01 Month 08 Day
Anticipated trial start date
2020 Year 01 Month 09 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047045

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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