UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045763 |
|---|---|
| Receipt number | R000052248 |
| Scientific Title | Muscle gain effect test by ingesting fish protein |
| Date of disclosure of the study information | 2021/10/19 |
| Last modified on | 2022/03/02 12:07:38 |
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Basic information
Public title
Muscle gain effect test by ingesting fish protein
Acronym
Muscle gain effect test by ingesting fish protein
Scientific Title
Muscle gain effect test by ingesting fish protein
Scientific Title:Acronym
Muscle gain effect test by ingesting fish protein
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of fish protein on increasing muscle strength and skeletal muscle mass.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lean body mass(muscle mass)(DEXA)
Key secondary outcomes
Lean body mass (Muscle mass)(Inpedance)
Knee extension
Grip strength
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Dissolve 1 bag(120g) of research food daily in 120cc of hot water and ingest for 12 weeks.
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) A Japanese woman whose age at the
time of obtaining consent is 65 years
or older.
2) Those who do not have a serious illness
3) Those who can visit designated examinations and fill in records
4) Those who have received sufficient explanation about the purpose and content of the research and have voluntarily agreed to participate in writing
Key exclusion criteria
1) Those who need support/care
2) Those with drug and food allergies (dairy, chicken, soy) that affect the study
3) Those who are considered to be hypersensitive to research foods
4) Those who have an exercise habit of 3 times or more a weeks
5) Those with irregular lifestyles
6) Those who have a pacemaker on their heart
7) Those with joint pain or restricted movement of the knees and lower back
8) Those with dysfunction of eating and swallowing
9) Those with walking dysfunction
10) Those who have been diagnosed
or treated for severe diabetes or chronic kidney disease
11) Those who drink more than 20g of alcohol per day
12) Those who smoke more than 20 cigarettes per day
13) Those who cannot refrain from inoculating foods for specified health use, foods with functional claims, and other so-called health foods during the research period
14) Those who cannot take research foods as instruct
15) Participants in other clinical trials or studies
16) Those who cannot follow the doctor's instructions, or those that the doctor deems inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nagazumi |
Organization
kanauchi medical clinic
Division name
director
Zip code
160-0023
Address
7-5-25 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3365-5521
office@kmc.or.jp
Public contact
Name of contact person
| 1st name | Sochi |
| Middle name | |
| Last name | Yoneda |
Organization
Mibyou Life Science inc
Division name
Clinical Trials Division
Zip code
101-0061
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL
03-6256-9600
Homepage URL
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science inc
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan kaisha,Ltd.
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
Mibyou Reserch Square Association
Address
2-18-4 kanda-misakicho chiyoda-ku, Tokyo, Japan
Tel
03-6272-9163
renraku@npo-mibyou.com
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
医療法人社団菱秀会 金内メディカルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 19 | 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
30
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
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 26 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052248
