UMIN-CTR Clinical Trial

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
Email	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
Email	renraku@mibyou-ls.com

Sponsor
Institute	Mibyou Life Science inc
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052248