UMIN-CTR Clinical Trial

Basic information
Public title	Effects of intake of Alaska pollock protein for muscular mass and strength, and quality of life in elderly people using long-term care service
Acronym	Effects of Alaska pollock protein for muscular mass and strength, and QOL
Scientific Title	Effects of intake of Alaska pollock protein for muscular mass and strength, and quality of life in elderly people using long-term care service
Scientific Title:Acronym	Effects of Alaska pollock protein for muscular mass and strength, and QOL
Region	Japan

Condition
Condition	Frailty
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of Alaska pollock protein intake for muscular mass and strength, and quality of life in elderly people using long-term care service
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle mass, muscle strength, 5 times chair stand test, gait speed, QOL
Key secondary outcomes	Nutritional status, lower thigh circumference, body weight, body fat mass

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	Treatment
Type of intervention	Food
Interventions/Control_1	All participants are taken the Alaska pollock protein powder with 120 ml of hot water once a day for 12 weeks. Before and after the 12-week intervention, physical examination and questionnaire are performed.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects are elderly people aged over 65 years using long-term care service.
Key exclusion criteria	People with cardiac pacemaker, arthralgia such as knees and hips, dysphagia, movement disability, diet therapy, diabetes and chronic kidney disease are excluded. In addition, people with habitual resistance exercise of high intensity load, and food allergies (fish, milk, soy, chicken) are excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroyasu Middle name Last name Mori
Organization	Tokushima University
Division name	Diabetes Therapeutics and Research Center
Zip code	7708503
Address	3-8-15 Kuramoto-cho, Tokushima-city
TEL	0886337587
Email	mori.hiroyasu@tokushim-u.ac.jp

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Mori
Organization	Tokushima University
Division name	Diabetes Therapeutics and Research Center
Zip code	7708503
Address	3-8-15 Kuramoto-cho, Tokushima-city
TEL	0886337587
Homepage URL
Email	mori.hiroyasu@tokushim-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Nippom Suisan Kaisha,Led. Functional,ingredient research section food function R&D center.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushima University
Address	3-8-15 Kuramoto-cho, Tokushima-city
Tel	0886339294
Email	first-ec@tokushima-u.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	2021 Year 09 Month 01 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	Main results already published
Date of protocol fixation	2021 Year 07 Month 05 Day
Date of IRB	2019 Year 08 Month 27 Day
Anticipated trial start date	2019 Year 09 Month 15 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 05 Day
Last modified on	2022 Year 02 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042514