UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028176
Receipt number R000032241
Scientific Title Effects of the number of chews on digestion, absorption, and metabolism
Date of disclosure of the study information 2017/07/11
Last modified on 2020/01/13 15:21:49

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Basic information

Public title

Effects of the number of chews on digestion, absorption, and metabolism

Acronym

Chewing and postprandial physiological response

Scientific Title

Effects of the number of chews on digestion, absorption, and metabolism

Scientific Title:Acronym

Chewing and postprandial physiological response

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of the number of chews on digestion, absorption, and metabolism

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Diet-induced thermogenesis
2) Splanchnic blood flow
3) Gastric emptying
4) 13C breath test
5) Ghrelin, Peptide YY

Key secondary outcomes

Gas exchange variables, Blood parameters, Subjective appetite by visual analog scale


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food Behavior,custom

Interventions/Control_1

To assess digestion, absorption, and metabolism after chewing almonds 10 times per a bite and then consuming them.

Interventions/Control_2

To assess digestion, absorption, and metabolism after chewing almonds 25 times per a bite and then consuming them.

Interventions/Control_3

To assess digestion, absorption, and metabolism after chewing almonds 40 times per a bite and then consuming them.

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

30 years-old >=

Gender

Male

Key inclusion criteria

1) Subjects who are aged 20-30 years old.
2) Subjects who are males.
3) Subjects who have not chronic diseases.
4) Subjects who are not having medication (including supplements).
5) Subjects who are non-smoker.
6) Subjects who have not reduced weight within the past 3 months or who do not lose weight within the examination period.
7) Subjects who are not participating another study.
8) Subjects who can consume all test meals and drinks.
9) Subjects who are being evaluated splanchnic blood flow and gastric emptying with ultrasound.

Key exclusion criteria

1) Subjects who are not aged 20-30 years old.
2) Subjects who are females.
3) Subjects who have chronic diseases.
4) Subjects who are having medication (including supplements).
5) Subjects who are smoker.
6) Subjects who have reduced weight within the past 3 months or who do lose weight within the examination period.
7) Subjects who are participating another study.
8) Subjects who can not consume because allergy foods are included in the test meals provided within the present study.
9) Subjects who are not being evaluated splanchnic blood flow and gastric emptying with ultrasound.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Miyashita

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

3591192

Address

2-579-15 Mikajima, Tokorozawa, Saitama

TEL

04-2947-6774

Email

m.miyashita@waseda.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Miyashita

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

591192

Address

2-579-15 Mikajima, Tokorozawa, Saitama

TEL

04-2947-6774

Homepage URL


Email

m.miyashita@waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

The Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Waseda University Research Ethics Committee

Address

1-104, Totsukamachi, Shinjuku-ku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.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

早稲田大学(埼玉県)/Waseda University(Saitama)


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 11 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

2017 Year 07 Month 06 Day

Date of IRB

2017 Year 07 Month 05 Day

Anticipated trial start date

2017 Year 03 Month 31 Day

Last follow-up date

2018 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

2017 Year 07 Month 11 Day

Last modified on

2020 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name