UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050432 |
|---|---|
| Receipt number | R000057437 |
| Scientific Title | A study to investigate the effects of resistance training combined with supplementation of functional food ingredient on physical function. |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2025/07/16 11:39:21 |
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Basic information
Public title
A study to investigate the effects of resistance training combined with supplementation of functional food ingredient on physical function in the elderly : a randomized, double-blind, placebo controlled, parallel-group comparative study.
Acronym
A study to investigate the effects of resistance training combined with supplementation of functional food ingredient on physical function.
Scientific Title
A study to investigate the effects of resistance training combined with supplementation of functional food ingredient on physical function.
Scientific Title:Acronym
A study to investigate the effects of resistance training combined with supplementation of functional food ingredient on physical function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of resistance training combined with orally administrated funtional food ingredient on physical function in the elderly and the efficacy to prevent sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle thickness
1. Actual measurement values at middle measurement point(6weeks after intervention;6w) and end measurement point(12 weeks after intervention;12w)
2. Amount of change and rate of change at 6w and 12w from baseline(before intervention;0w)
Key secondary outcomes
Maximum walking speed, normal walking speed, the 30-s chair stand test(CS-30) and body composition
1. Actual measurement values at middle measurement point(6weeks after intervention;6w) and end measurement point(12 weeks after intervention;12w)
2. Amount of change and rate of change at 6w and 12w from baseline(before intervention;0w)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Pilot study: Intake of test food containing lemon myrtle extract for 12 weeks and moderate-intensity resistance training for 12weeks.
Interventions/Control_2
Pilot study: Intake of placebo food not containing lemon myrtle extract for 12 weeks and moderate-intensity resistance training for 12 weeks.
Interventions/Control_3
Intake of test food containing lemon myrtle extract for 12 weeks and mild-intensity resistance training for 12weeks.
Interventions/Control_4
Intake of placebo food not containing lemon myrtle extract for 12 weeks and mild-intensity resistance training for 12 weeks.
Interventions/Control_5
Intake of test food containing lemon myrtle extract for 12 weeks and moderate-intensity resistance training for 12weeks.
Interventions/Control_6
Intake of placebo food not containing lemon myrtle extract for 12 weeks and moderate-intensity resistance training for 12 weeks.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are over 65 years old and healthy males and females.
2. Subjects who are aware of getting worse of muscle mass or muscle strength.
3. Subjects who have the trend of decrease in muscle mass.
Key exclusion criteria
1. Subjects who take antidiabetic medicines.
2. Subjects who are prohibited from exercising by a doctor.
3. Subjects with symptoms that interfere with training, such as lower back pain or arthralgia.
4. Subjects who take supplements ,functional foods or medicines in order to improve of symptoms related to muscle or arthrosis on a daily basis.
5. Subjects who go to health club on a daily basis.
6. Subjects who are considerably undernutrition.
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695, Japan
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695, Japan
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Keneka corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba
Tel
0476-98-1001
sc-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
| 2024 | Year | 05 | Month | 30 | 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
| 2023 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057437
