UMIN-CTR Clinical Trial

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	Completed
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	2020 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	2018 Year 10 Month 17 Day
Last modified on	2020 Year 04 Month 22 Day

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