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

Email

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


Email

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

Email

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