UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038625 |
|---|---|
| Receipt number | R000043577 |
| Scientific Title | Effects of a single bout of walking on postprandial cardio-metabolic risk markers in South Asian, European and Japanese adults |
| Date of disclosure of the study information | 2019/11/19 |
| Last modified on | 2023/05/23 09:46:10 |
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Basic information
Public title
Effects of a single bout of walking on postprandial metabolism in South Asian, European and Japanese adults
Acronym
Effects of walking on postprandial metabolism: A cross-national study
Scientific Title
Effects of a single bout of walking on postprandial cardio-metabolic risk markers in South Asian, European and Japanese adults
Scientific Title:Acronym
Effects of walking on postprandial cardio-metabolic risk markers: A cross-national study
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of a single bout of walking on postprandial cardio-metabolic risk markers betweeen South Asian, European and Japanease adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood lipid and carbohydrate parameters
Key secondary outcomes
Anthropometry, Blood pressure, Gas data during exercise, Heart rate, Daily physical activity levels, Subjective feelings of appetite
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Healthy young adult men peform 60 minutes walking, on the following day, postprandial glucose and lipids are evaluated after consuming breakfast.
Interventions/Control_2
Healthy young adult men rest, on the following day, postprandial glucose and lipids are evaluated after consuming breakfast.
Interventions/Control_3
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
| 21 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1 - Age between 21 and 39 years old.
2 - Men
3 - A participant who is able to perform 60-minutes walking exercise
4 - Non smoker
5 - A paticipant who is not performed his weight loss in the past three months and who has no intentino to weight loss during the study.
6 - Not participate in other studies during the study and currently not involve in other studies as a participant
7 - A participant who is able to consume the test meal in the study
Key exclusion criteria
1 - Not age between 21 and 39 years old.
2 - Women
3 - A participant who has surgical/medical diseases and is difficult to perform 60-minutes walking exercise
4 - Smoker
5 - A paticipant who is performed his weight loss in the past three months and who has an intentino to weight loss during the study.
6 - Participate in other studies during the study and currently involve in other studies as a participant
7 - Participant who is not able to consume the test meal in the study due to allergy
Target sample size
60
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
Waseda University
Organization
Division
Category of Funding Organization
Other
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
0352721639
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 | 11 | Month | 19 | 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 | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 20 | 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 | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043577
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| Registered date | File name |
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