UMIN-CTR Clinical Trial

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