UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035254 |
|---|---|
| Receipt number | R000040044 |
| Scientific Title | The effects of resistance training and calorie increase on the metabolsim and body composition of postmenopausal women |
| Date of disclosure of the study information | 2018/12/14 |
| Last modified on | 2022/06/21 04:58:38 |
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Basic information
Public title
The effects of resistance training and calorie increase on the metabolsim and body composition of postmenopausal women
Acronym
Metabolism improvement via increase of muscle mass
Scientific Title
The effects of resistance training and calorie increase on the metabolsim and body composition of postmenopausal women
Scientific Title:Acronym
Metabolism improvement via increase of muscle mass
Region
| Japan |
Condition
Condition
Postmenopausal women age 50~65 with the following restricitons:
-BMI between 16.0~18.5 kg/m2
-Blood glucose over 140mg/dL 2 hours after OGT
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate if resistance training and calorie increase can improve glucose metabolism in postmenopausal women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Glucose metabolism after resistance trainig and increase diet
Key secondary outcomes
1) Body weight, Body fat
2) Muscle strength
3) Bone mass and muscle mass
4) VO2 MAX
5) Thigh CSA
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
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
increase in resistance training and calories
Interventions/Control_2
control
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Postmenopausal women between 50~65 with BMI 16~18.5kg/m2 and blood glucose 140mg/dL 2 hours after OGT (75g)
Key exclusion criteria
(Exclusion criteria)
-Those who understand the contents of the research by the document and can not obtain consent from the document
-Before menopause, within 1 year from the last menstruation
-Persons suffering from menopause due to gynecological diseases
-Persons with mental illness including nervous anorexia
-Those with hyperthyroidism
-Persons who have underlying diseases such as liver disease, kidney disease, heart disease, diabetes, dyslipidemia, collagen disease
-People suffering from malignant tumors
-Those who regularly take supplements, herbal medicines, diuretics or laxatives
-Excessive drinkers
-Persons who routinely train, those belonging to competition groups and aiming for competitions etc.
-Others who judged inappropriate by the examining physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Tamura |
Organization
Juntendo University
Division name
Department of Metabolism and Endocrinology/ Sportology Center
Zip code
113-8421
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-5802-1579
ys-tamur@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Tamura |
Organization
Juntendo University
Division name
Department of Metabolism and Endocrinology/ Sportology Center
Zip code
113-8421
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-5802-1579
Homepage URL
ys-tamur@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Techonology
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
The ethics committee of Juntendo University
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
Tel
03-3813-3176
rinri@juntendo.ac.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
| 2018 | Year | 12 | Month | 14 | 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
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2018 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040044
