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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028176
Receipt No. 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 2018/01/24

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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
Middle name
Last name Masashi Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6774
Email m.miyashita@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 14 Day
Last follow-up date
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
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.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


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