UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037420 |
|---|---|
| Receipt number | R000042405 |
| Scientific Title | Effect of accmulating physical activity on postprandial carbohydrate and lipid metabolism in postmenopausal women |
| Date of disclosure of the study information | 2019/07/18 |
| Last modified on | 2020/04/13 08:29:41 |
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Basic information
Public title
Effect of physical activity on postprandial metabolism in older women
Acronym
Effect of physical activity on postprandial metabolism
Scientific Title
Effect of accmulating physical activity on postprandial carbohydrate and lipid metabolism in postmenopausal women
Scientific Title:Acronym
Effect of accmulating physical activity on postprandial metabolism in postmenopausal women
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of increased daily physical activity on postprandial triglyceride in postmenopausal women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglyceride
Key secondary outcomes
Anthropometry,
Other blood lipid and carbohydrate parameters, heart rate, blood pressure, and
Physical function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Participants perform physical activity through their daily life at self-selected intensity, duration and frequency over 3 months. Fasting and postprandial triglyceride concentrations were evaluated over 6 months at baseline, 1 month after the commencement of research, 2 months after the commencement of research and 3 months after the commencement of research.
Interventions/Control_2
Participants maintain their daily life over 3 months. Fasting and postprandial triglyceride concentrations were evaluated over 6 hours at baseline, 1 month after the commencement of research, 2 months after the commencement of research and 3 months after the commencement of research.
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
1 - Age between 55 and 85 years old.
2 - Women
3 - No surgical diseases
4 - Postmenopausal women
5 - No smoker
6 - Paticipant who is not performed her weight loss in the past three months and who has no intentino to weight loss during the study.
7 - Not participate in other studies during the study and currently not involve in other studies as a participant
8 - Participant who is able to consume the test meal in the study
Key exclusion criteria
1- Not age between 55 and 85 years old.
2 - Men
3 - has surgical diseases
4 - Not postmenopausal women
5 - Smoker
6 - Paticipant who is performed her weight loss in the past three months and who has an intentino to weight loss during the study.
7 - Participate in other studies during the study and currently involve in other studies as a participant
8 - Participant who is not able to consume the test meal in the study
Target sample size
40
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
Japan Society for the Promotion of Science
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
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 | 07 | Month | 18 | 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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | 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 | 07 | Month | 18 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042405
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
