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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035718
Receipt No. R000040691
Scientific Title Intervention study on intake of Alaska pollack soup for sarcopenia prevention in community-dwelling elderly
Date of disclosure of the study information 2019/04/01
Last modified on 2020/01/23

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Basic information
Public title Intervention study on intake of Alaska pollack soup for sarcopenia prevention in community-dwelling elderly
Acronym Intervention study of Alaska pollack soup for sarcopenia prevention
Scientific Title Intervention study on intake of Alaska pollack soup for sarcopenia prevention in community-dwelling elderly
Scientific Title:Acronym Intervention study of Alaska pollack soup for sarcopenia prevention
Region
Japan

Condition
Condition Sarcopenia
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For the purpose of prevention of sarcopenia, we will clarify the influence of ingesting Alaska pollack soup once a day on the increase of skeletal muscle mass and muscle strength of the elderly and improvement of health-related quality of life in a randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skeletal muscle mass, grip strength, leg power.
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 YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 For 24 weeks, once a day, ingest the Alaska pollack-derived powder with 120 ml of hot water at breakfast.
Interventions/Control_2 For 24 weeks, once a day, ingest the whey milk-derived powder with 120 ml of hot water at breakfast.
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
90 years-old >
Gender Female
Key inclusion criteria Applicant for Sarcopenia(diagnostic criteria of Asian Working Group for Sarcopenia. SMI, grip strength,gait speed < cutoff value)
Key exclusion criteria Diabetes, CKD, resistance trainded elderly, joint and motor dysfunction, difficult to eat meals, food allergy (fish, milk, soybeans, chicken)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mori
Middle name
Last name Hiroyasu
Organization University of Tokushima
Division name Diabetes Therapeutics and Research Center
Zip code 7708503
Address 3-18-15 Kuramoto, Tokushima, Tokushima 770-8503, Japan
TEL 0886337587
Email mori.hiroyasu@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Mori
Middle name
Last name Hiroyasu
Organization University of Tokushima
Division name Diabetes Therapeutics and Research Center
Zip code 7708503
Address 3-18-15 Kuramoto, Tokushima, Tokushima 770-8503, Japan
TEL 0886337587
Homepage URL
Email mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute University of Tokushima, Diabetes Therapeutics and Research Center
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 University of Tokushima
Address 3-18-15 Kuramoto, Tokushima, Tokushima 770-8503, Japan
Tel 0886337587
Email mori.hiroyasu@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
2019 Year 04 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 100
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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 Month 21 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 01 Month 30 Day
Last modified on
2020 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040691

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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