UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038346 |
|---|---|
| Receipt number | 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 | 2023/04/24 10:04:12 |
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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
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
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
11
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
| 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
| 2023 | 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
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043684
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| Registered date | File name |
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