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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028162
Receipt No. R000032236
Scientific Title The effectiveness of accumulating physical activity on postprandial metabolism in postmenopausal women
Date of disclosure of the study information 2017/07/10
Last modified on 2019/07/11

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Basic information
Public title The effectiveness of accumulating physical activity on postprandial metabolism in postmenopausal women
Acronym The effects of accumulating physical activity on postprandial metabolism
Scientific Title The effectiveness of accumulating physical activity on postprandial metabolism in postmenopausal women
Scientific Title:Acronym The effects of accumulating physical activity on postprandial metabolism
Region
Japan

Condition
Condition Adults
Classification by specialty
Endocrinology and Metabolism Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of accumulating physical activity on postprandial triglycerides in postmenopausal women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Postprandial triglycerides
Key secondary outcomes Anthropometry, blood parameters, heart rate, blood pressure, rating of perceived exertion scale

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Participants rest 8h. Blood samples are collected in the fasted state and then every 2h until 8h, and blood pressure are collected in the fasted state and then every 1h until 8h. Participants consume a breakfast (09:00) and lunch (12:00).
Interventions/Control_2 Participants rest 8h and walk briskly twenty, 90-sec bouts over 8h (10:00-16:30). Blood samples are collected in the fasted state and then every 2h until 8h, and blood pressure are collected in the fasted state and then every 1h until 8h. Participants consume a breakfast (09:00) and lunch (12:00).
Interventions/Control_3 Participants rest 8h and walk briskly twenty, 90-sec bouts over 8h (10:00-16:30). Blood samples are collected in the fasted state and then every 2h until 8h, and blood pressure are collected in the fasted state and then every 1h until 8h. Participants consume a breakfast (09:00) and lunch (12:00). The exercise-induced net energy expenditure
is replaced equally for breakfast and lunch.
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
80 years-old >=
Gender Female
Key inclusion criteria 1)Subjects who are aged 55-80 years old
2)Subjects who are females
3)Subjects who have not surgical diseases
4)Subjects who are non-smoker
5)Subjects who are postmenopause
6)Subjects who are not participating another study
7)Subjects without a history of allergy or might not be liable to allergy related to the study
Key exclusion criteria 1)Subjects who are not aged 55-80 years old
2)Subjects who are males
3)Subjects who have surgical diseases
4)Subjects who are smoker
5)Subjects who are not postmenopause
6)Subjects who are participating another study
7)Subjects with a history of allergy or might be liable to allergy related to the study
Target sample size 30

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 Japan Society for the Promotion of Science
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 Research Ethics Committee
Address 1-104, Totsukamachi, 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 早稲田大学(埼玉県)/Waseda University(Saitama)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 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
2017 Year 06 Month 13 Day
Date of IRB
2017 Year 07 Month 10 Day
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
2019 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
2017 Year 07 Month 10 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032236

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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