UMIN-CTR Clinical Trial

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
Institute	Waseda University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032241