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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043331
Receipt No. R000049466
Scientific Title Influence on blood glucose level, drowsiness and concentration by meal intake for healthy adults.
Date of disclosure of the study information 2021/02/23
Last modified on 2021/02/15

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Basic information
Public title Influence on blood glucose level, drowsiness and concentration by meal intake for healthy adults.
Acronym Influence on blood glucose level, drowsiness and concentration by meal intake for healthy adults.
Scientific Title Influence on blood glucose level, drowsiness and concentration by meal intake for healthy adults.
Scientific Title:Acronym Influence on blood glucose level, drowsiness and concentration by meal intake for healthy adults.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the influence on blood glucose level, drowsiness and concentration by meal intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Area under the curve of blood glucose level
Key secondary outcomes Postprandial blood glucose level (30, 60, 90, 120 min)
Postprandial drowsiness (30, 60, 90, 120 min)
Postprandial autonomic function (30, 60, 90, 120 min)
Postprandial performance (30, 60, 90, 120 min)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Intake of test food (single ingestion) - washing out (7 days or more) - intake of placebo (single ingestion)
Interventions/Control_2 Intake of placebo (single ingestion) - washing out (7 days or more) - intake of test food (single ingestion)
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
49 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females from 30 to 49 years of age
Key exclusion criteria (1)Subjects having food allergy
(2)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(3)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4)Subjects who have participated in other clinical study when the current study starts
(5)Subjects who intend to become pregnant or lactating
(6)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Jiro
Middle name
Last name Saito
Organization Medical Station Clinic
Division name None
Zip code 152-0004
Address 3-12-8, Takaban, Meguro-ku, Tokyo, Japan
TEL 03-6452-2712
Email info@med-station.jp

Public contact
Name of contact person
1st name Yoshimi
Middle name
Last name Bansho
Organization EP Mediate Co., Ltd.
Division name Development Business Headquarters, TTC Center, Trial Planning Department
Zip code 162-0822
Address Tsuruya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL 03-5657-4983
Homepage URL
Email bansho189@eps.co.jp

Sponsor
Institute EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization non-disclosure
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 Medical Station Clinic Research Ethics Committee
Address 3-12-8, Takaban, Meguroku, Tokyo
Tel 080-2290-2544
Email makabe295@eps.co.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
2021 Year 02 Month 23 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 14 Day
Date of IRB
2021 Year 01 Month 14 Day
Anticipated trial start date
2021 Year 02 Month 23 Day
Last follow-up date
2021 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 15 Day
Last modified on
2021 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049466

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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