UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034542
Receipt number 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 2020/04/22 10:22:14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



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

Value
https://center6.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