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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037420
Receipt No. 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 2020/01/17

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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
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 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
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 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 No longer recruiting
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 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042405

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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