UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023444 |
|---|---|
| Receipt number | R000027017 |
| Scientific Title | The effects of accumulating exercise on postprandial triglycerides in postmenopausal, hypertriglyceridemia women |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2019/08/05 09:08:54 |
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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
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
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027017
