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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038346
Receipt No. R000043684
Scientific Title The effects of exercise intensity and nutritional supplementation immediately postexercise on digestion, absorption, metabolism and appetite
Date of disclosure of the study information 2019/10/23
Last modified on 2020/04/21

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Basic information
Public title The effects of exercise intensity and nutritional supplementation immediately postexercise on digestion, absorption, metabolism and appetite
Acronym The effects of exercise intensity and postexercise nutritional supplementation on physiological responses
Scientific Title The effects of exercise intensity and nutritional supplementation immediately postexercise on digestion, absorption, metabolism and appetite
Scientific Title:Acronym The effects of exercise intensity and postexercise nutritional supplementation on physiological responses
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 exercise intensity and nutritional supplementation immediately postexercise on digestion, absorption, metabolism and appetite.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) 13C-breath test
2) Splanchnic blood flow
3) Cross sectional antral area of stomach
4) Appetite-related hormones
5) Diet-induced thermogenesis
Key secondary outcomes 1) Blood parameters
2) Subjective appetite by visual analogue scale (VAS)
3) Gas exchange variables

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 Treatment
Type of intervention
Food
Interventions/Control_1 After 60-min of resting, digestion, absorption, metabolism and appetite are assessed over 90 min after glucose/protein-containing drink ingestion.
Interventions/Control_2 After 60-min of running at 40% of maximum heart rate, digestion, absorption, metabolism and appetite are assessed over 90 min after glucose/protein-containing drink ingestion.
Interventions/Control_3 After 60-min of running at 70% of maximum heart rate, digestion, absorption, metabolism and appetite are assessed over 90 min after glucose/protein-containing drink ingestion.
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
29 years-old >=
Gender Male
Key inclusion criteria 1) Subjects who are aged 20-29 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 imaging systems.
Key exclusion criteria 1) Subjects who are not aged 20-29 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 imaging systems.
Target sample size 16

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 359-1192
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 359-1192
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 Ministry of Education, Culture, Sports, Science and Technology
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 Waseda University
Address 1-104, Totsuka-cho, 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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 23 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
2019 Year 08 Month 20 Day
Date of IRB
2019 Year 10 Month 15 Day
Anticipated trial start date
2019 Year 10 Month 23 Day
Last follow-up date
2021 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
2019 Year 10 Month 21 Day
Last modified on
2020 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043684

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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