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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034542
Receipt No. R000037934
Scientific Title Effect of chewing on anabolic hormones in healthy adults
Date of disclosure of the study information 2018/10/17
Last modified on 2019/04/18

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Basic information
Public title Effect of chewing on anabolic hormones in healthy adults
Acronym Effect of chewing on anabolic hormones in healthy adults
Scientific Title Effect of chewing on anabolic hormones in healthy adults
Scientific Title:Acronym Effect of chewing on anabolic hormones in healthy adults
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess effect of chewing on anabolic hormones such as ghrelin, growth hormone and insulin in healthy adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of anabolic hormones before and after the intervention
Key secondary outcomes The change of blood glucose and insulin before and after the intervention

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 After collecting data before intervention, ingest 1 gummy containing protein. At this time, this group chews about 300 times. Data is collected after intervention every several minutes. From the following day, exchange the chewing group and non-chewing group and collect data and intervention.
Interventions/Control_2 After collecting data before intervention, ingest 1 gummy containing protein. At this time, this group ingests the finely crushed gummy without chewing. Data is collected after intervention every several minutes. From the following day, exchange the chewing group and non-chewing group and collect data and intervention.
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
49 years-old >=
Gender Male and Female
Key inclusion criteria The healthy volunteers who agreed with the purpose of this research.
Key exclusion criteria Person who is pointed out impaired glucose tolerance and diabetes.
Person who has history or surgery of stomach, intestine and pancreas.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Ikeda
Organization Kyoto University Hospital
Division name Department of Diabetes, Endocrinology and Nutrition
Zip code 6068057
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, JAPAN
TEL 075-751-3560
Email krikeda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Kaori
Middle name
Last name Ikeda
Organization Kyoto University Hospital
Division name Department of Diabetes, Endocrinology and Nutrition
Zip code 6068507
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, JAPAN
TEL 075-751-3560
Homepage URL
Email krikeda@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Society For The Promotion Of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, JAPAN
Tel 075-753-4642
Email ethcom@kuhp.kyoto-u.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
2018 Year 10 Month 17 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
2018 Year 10 Month 17 Day
Date of IRB
2018 Year 10 Month 17 Day
Anticipated trial start date
2019 Year 02 Month 27 Day
Last follow-up date
2019 Year 10 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037934

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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