UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045069 |
|---|---|
| Receipt number | R000051469 |
| Scientific Title | Influence of nucleotide on muscle atrophy |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2025/02/06 12:01:56 |
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Basic information
Public title
Influence of nucleotide on muscle atrophy
Acronym
Influence of nucleotide on muscle atrophy
Scientific Title
Influence of nucleotide on muscle atrophy
Scientific Title:Acronym
Influence of nucleotide on muscle atrophy
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the influence of nucleotide on muscle atrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
muscle atrophy
Key secondary outcomes
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Nucleotide, 14 days
Interventions/Control_2
Placebo (cellulose), 14 days
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) BMI of less than 30 kg/m2
(2) Must be in good physical condition and able to perform the test safely
(3) Those who voluntarily participate in the test with written consent
Key exclusion criteria
(1) Those who have metal or other objects in their body that prevent them from performing MRI measurements.
(2) Those who routinely perform upper limb training.
(3) Patients with glucose metabolism disorder, endocrine disorder, kidney, liver, or digestive organ disease.
(4) Patients undergoing medical treatment by a physician.
(5) Those who have been diagnosed as suffering from heart disease.
(6) Patients with type I or type II diabetes
(7) Those who have been diagnosed as requiring treatment or re-examination at a medical check-up within the past year
(8) Those who participated in another clinical trial within the last 3 months
(9) Those who have used illicit drugs in the last 6 months.
(10) Patients who have had alcoholism or drug addiction in the last 6 months
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kubota |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
2701695
Address
1-1, Hiragagakuendai, Inzai, Chiba
TEL
+81476981001
akubota@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kubota |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
2701695
Address
1-1, Hiragagakuendai, Inzai, Chiba
TEL
+81476981001
Homepage URL
akubota@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
YAMASA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address
1-1, Hiragagakuenndai, Inzai, Chiba
Tel
+81476981001
sc-kyomu@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
順天堂大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://x.gd/bINX9
Publication of results
Published
Result
URL related to results and publications
https://x.gd/bINX9
Number of participants that the trial has enrolled
22
Results
Results: Both groups showed a significant decrease in muscle thickness at MT70. The relative decrease was greater in the placebo group (2.4 +- 2.8%) than in the UMP group (0.0 +- 2.0%), significantly (p = 0.034) at 1 week. However, no significant difference was observed at MT50 and MT60.
Results date posted
| 2025 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 22 healthy men were enrolled in this study. The inclusion criteria were defined as follows: (1) age exceeding 20 and below 25 years, (2) BMI not more than 30 kg/m2, (3) satisfactory physical condition with the ability to safely perform the experiment, and (4) provision of written consent and voluntary participation in the experiment. Conversely, exclusion criteria comprised (1) regular upper extremity training; (2) presence of glucose metabolism disorders, endocrine disorders, kidney/liver disease, and digestive disease; (3) current medical medication prescribed by a doctor; (4) diagnosed heart disease; (5) type I or type II diabetes; (6) a physical examination within the past year requiring treatment or reexamination; (7) participation in another clinical experiment within the past 3 months; (8) use of illicit drugs within the past 6 months; or (9) a history of alcoholism or drug addiction within the past 6 months. The study's purpose and methods were communicated verbally and in writing to the participants, who then provided written consent.
Participant flow
One participant opted not to continue for personal reasons before controlled trial. The remaining 21 participants were randomly assigned to two groups: (1) receiving 5'-UMP, 2Na (UMP group, n = 11) and (2) a placebo group (n = 10), and they were allowed to consume the assigned test supplement during the 2-week detraining phase. Measurements were taken weekly during the detraining period, and data from the 21 participants who completed the study were used for analysis.
Adverse events
No adverse events were observed.
Outcome measures
Muscle thickness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 08 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 08 | 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 | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051469
