UMIN-CTR Clinical Trial

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
Email	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
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	The ethics committee of Juntendo University
Address	Hongo 2-1-1, Bunkyo-ku, Tokyo
Tel	03-3813-3176
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040044