UMIN-CTR Clinical Trial

Basic information
Public title	The effects of accumulating exercise on postprandial triglycerides in postmenopausal, hypertriglyceridemia women
Acronym	The effects of accumulating exercise on postprandial triglycerides
Scientific Title	The effects of accumulating exercise on postprandial triglycerides in postmenopausal, hypertriglyceridemia women
Scientific Title:Acronym	The effects of accumulating exercise on postprandial triglycerides
Region	Japan

Condition
Condition	Adults
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Postprandial triglycerides
Key secondary outcomes	Anthropometry, blood parameters, heart rate, blood pressure, ratings 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 30 min in the morning (10:00-10:30). Blood samples are collected in the fasted state and ten 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).
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	65 years-old <=
Age-upper limit	85 years-old >=
Gender	Female
Key inclusion criteria	Postmenopausal and fasting triglyceride concentration above 150mg/dl women giving written informed consent.
Key exclusion criteria	1)Subjects who are smoker 2)Subjects with a history of allergy or might be liable to allergy related to the study 3)Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system 4)Subjects who are ineligible due to physician's judgment 5)Subjects who participate in other clinical trials 6)Subjects who are ineligible due to a result of the prior blood measurement
Target sample size	15

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	3591192
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	Waseda University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Waseda Univeristy
Address	1-104, Totsuka-cho, 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）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 03 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	2016 Year 07 Month 11 Day
Date of IRB	2016 Year 08 Month 03 Day
Anticipated trial start date	2016 Year 08 Month 03 Day
Last follow-up date	2017 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	2016 Year 08 Month 02 Day
Last modified on	2019 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027017