UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038253 |
|---|---|
| Receipt number | 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 | 2025/04/15 17:40:58 |
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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
Resistance training for 12 weeks
Interventions/Control_4
Resistance training with meat intake:
Intake of meat for 3 days / week
Resistance 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
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
iemitsu@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/39569460/ and https://pubmed.ncbi.nlm.nih.gov/38888088/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39569460/ and https://pubmed.ncbi.nlm.nih.gov/38888088/
Number of participants that the trial has enrolled
93
Results
Muscle strength, muscle volume, and echo intensity improved significantly after both resistance training (RT) and RT with meat intake (MI). Arterial stiffness indices were significantly higher in the RT group compared to the control, but no differences were observed between the RT with MI and control groups. Gut microbiota composition remained unchanged across all groups.
Results date posted
| 2025 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All participants were recruited through newspaper advertisements in Otsu, Kusatsu, and Ritto City in Shiga, Japan.
All participants were informed of the experimental procedures and risks, and provided written informed consent before participating in the study.
Participant flow
The study commenced after obtaining informed consent from the participants. Initial pre-measurements were conducted, and the participants were randomly assigned to different groups. Subsequently, interventions were carried out for 12 weeks in each group, followed by post-measurements conducted at the end of the 12-week period.
Adverse events
None
Outcome measures
Anthropometric measures
Body composition (Fat mass, %body fat, the Leen body mass)
Blood pressures and hear rate
Arterial stiffness indices (pulse wave velocity, beta-stiffness)
Muscle strength (maximum knee extension muscle strength, one-repetition maximum)
Muscle echo intensity
Muscle thickness
Cross-sectional area of the muscle
Physical activity, energy intake, and nutritional status
Gut microbiota
Blood parameters
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 | 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
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043607
