UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037288 |
|---|---|
| Receipt number | R000042514 |
| 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 |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/02/01 09:34:19 |
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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
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
mori.hiroyasu@tokushim-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042514
