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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035255
Receipt No. R000040068
Scientific Title Influence of unsupervised resistance training and dietary increase in menopausal women in metabolism / body composition
Date of disclosure of the study information 2018/12/14
Last modified on 2018/12/14

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Basic information
Public title Influence of unsupervised resistance training and dietary increase in menopausal women in metabolism / body composition
Acronym Influence of unsupervised resistance training and dietary increase in menopausal women in metabolism / body composition
Scientific Title Influence of unsupervised resistance training and dietary increase in menopausal women in metabolism / body composition
Scientific Title:Acronym Influence of unsupervised resistance training and dietary increase in menopausal women in metabolism / body composition
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 verify the effect of exercise therapy and nutrition intake on skeletal muscle mass increase on menopausal women who are thin, and to clarify the influence on metabolism.
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 increase in calories
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
Middle name
Last name Tamura Yoshifumi
Organization Juntendo University
Division name Department of Metabolism and Endocrinology/ Sportology Center
Zip code
Address Tokyo Bunkyo Hongo 2-1-1
TEL 03-5802-1579
Email ys-tamur@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamura Yoshifumi
Organization Juntendo University
Division name Department of Metabolism and Endocrinology/ Sportology Center
Zip code
Address Tokyo Bunkyo Hongo 2-1-1
TEL 03-5802-1579
Homepage URL
Email ys-tamur@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 10 Day
Last follow-up date
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
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040068

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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