UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045605 |
|---|---|
| Receipt number | R000052067 |
| Scientific Title | Effects of Dioscorea esculenta intake and resistance training on risks of sarcopenia and metabolic syndrome |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2023/09/13 20:16:51 |
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Basic information
Public title
Effects of Dioscorea esculenta intake and resistance training on risks of sarcopenia and metabolic syndrome
Acronym
Effects of Dioscorea esculenta intake and resistance training on risks of sarcopenia and metabolic syndrome
Scientific Title
Effects of Dioscorea esculenta intake and resistance training on risks of sarcopenia and metabolic syndrome
Scientific Title:Acronym
Effects of Dioscorea esculenta intake and resistance training on risks of sarcopenia and metabolic syndrome
Region
| Japan |
Condition
Condition
middle aged and older adults
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects of chronic dioscorea esculentum intake and resistance exercise on risks of sarcopenia (muscle mass / strength) and metabolic syndrome in middle-aged and older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of 6-week and 12-week Dioscorea esculenta intake and resistance exercise on risks of sarcopenia (muscle mass, strength and function) and metabolic syndrome
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
4
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Sedentary with 2,000mg placebo intake:
Intake of 2,000 mg of placebo powder with calorie equivalent to the intake as 2,000 mg of dioscorea powder group
Interventions/Control_2
Sedentary with 2,000mg dioscorea powder intake:
Intake of 2,000 mg of dioscorea powder
Interventions/Control_3
12-week resistance training with 2,000mg placebo intake:
Resistance training for 12 weeks
Intake of 2,000 mg of placebo powder with calorie equivalent to the intake as 2,000 mg of dioscorea powder group
Interventions/Control_4
12-week resistance training with 2,000mg dioscorea powder intake:
Resistance training for 12 weeks
Intake of 2,000 mg of dioscorea powder
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who must ban or limit exercise therapy by the doctor
2) Subjects who do not have some therapies and/or medications
3) Subjects who are capable of making a decision by themselves, and provide written consent
4) Subjects who have the Internet environment and the knowledge of Web (Zoom, etc.) operation that can perform exercise training via the Web
Key exclusion criteria
1) Patients with obesity due to adrenal diseases
2) Patients with cardiovascular diseases
3) Patients with hepatic dysfunction
4) Patients with renal dysfunction (serum creatinine level: 3.0mg/dl or higher)
5) Pregnant or plans to become pregnant during the study period
6) Patients with limited exercise therapy
7) Others who judged inappropriate by the examining physician
8) Subjects who have food allergies to dioscorea and yam
9) Subjects who can not swallow supplement
10) Subjects who daily intake dioscorea and yam
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Motoyuki |
| Middle name | |
| Last name | Iemitsu |
Organization
Ritsumeikan University
Division name
Faculty of Sport 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
Faculty of Sport 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
JSPS KAKENHI for Scientific Research
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
Ethics committee of Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
0775613412
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
| 2021 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/15/11/2438
Number of participants that the trial has enrolled
66
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
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 29 | 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
| 2021 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052067
