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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038253
Receipt No. R000043607
Scientific Title Effects of combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome
Date of disclosure of the study information 2019/10/09
Last modified on 2019/10/09

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Basic information
Public title Effects of combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome
Acronym Effects of combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome
Scientific Title Effects of combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome
Scientific Title:Acronym Effects of combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome
Region
Japan

Condition
Condition middle-aged and older woman including of sarcopenia and/or metabolic syndrome
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effects of 12-week combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome in middle-aged and older woman.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of 12-week combination of meat intake and resistance training on risks of sarcopenia and metabolic syndrome and gut microbiota
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Sedentary with placebo intake:
Intake of carbohydrate with calories equivalent to the meat intake group
Interventions/Control_2 Sedentary with meat intake:
Intake of meat for 3 days / week
Interventions/Control_3 Resistance training with placebo intake:
Intake of carbohydrate with calories equivalent to the meat intake group
Resitance training for 12 weeks
Interventions/Control_4 Resistance training with meat intake:
Intake of meat for 3 days / week
Resitance training for 12 weeks
Interventions/Control_5 Aquatic resistance training with placebo intake:
Intake of carbohydrate with calories equivalent to the meat intake group
Aquatic resistance training for 12 weeks
Interventions/Control_6 Aquatic resistance training with meat intake:
Intake of meat for 3 days / week
Aquatic resistance training for 12 weeks
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
90 years-old >=
Gender Female
Key inclusion criteria 1)Subjects who must ban or limit exercise therapy by the doctor
2)Subjects who don't have some therapies and/or medications
3)Subjects who are capable of making a decision by themselves, and provide written consent
Key exclusion criteria 1)Patients with obesity due to adrenal diseases
2)Patients with cardiobasucular diseases
3)Patients with hepatic failure and renal failure
4)Pregnant or plants to become pregnant during the study period
5)Patients with limited exercise therapy
6)Others who judged inappropriate by the examining physician
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Motoyuki
Middle name
Last name Iemitsu
Organization Ritsumeikan University
Division name Facuity of Sports and Health Science
Zip code 525-8577
Address 1-1-1 Noji-higashi, Kusatsu, Shiga
TEL 0775994131
Email iemitsu@fc.ritsumei.ac.jp

Public contact
Name of contact person
1st name Motoyuki
Middle name
Last name Iemitsu
Organization Ritsumeikan University
Division name Facuity of Sports and Health Science
Zip code 525-8577
Address 1-1-1 Noji-higashi, Kusatsu, Shiga
TEL 0775994131
Homepage URL
Email iemitsu@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

Funding Source
Organization The Ito Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Grant-in-Aid for Scientific Reserch from the Ministry of Education, Culture, Science and Technoligy of Japan

IRB Contact (For public release)
Organization Ethics committee of Ritsumeikan University
Address 1-1-1 Noji-higashi, Kusatsu, Shiga
Tel 077-561-3412
Email b-rinri@st.ritsumei.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
2019 Year 10 Month 09 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
2018 Year 11 Month 19 Day
Anticipated trial start date
2019 Year 10 Month 09 Day
Last follow-up date
2022 Year 01 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
2019 Year 10 Month 09 Day
Last modified on
2019 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043607

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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