UMIN-CTR Clinical Trial

Basic information
Public title	Pre-frail New efforts to prevent the progression of frail by intervention of agarooligosaccharides in the elderly
Acronym	Trial that inhibits the progression of preflail
Scientific Title	Pre-frail New efforts to prevent the progression of frail by intervention of agarooligosaccharides in the elderly
Scientific Title:Acronym	Trial that inhibits the progression of preflail
Region	Japan

Condition
Condition	frail
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is a test study that functional foods do from frail to frail (weakness) in the elderly. It is a randomized controlled trial to reduce the walking speed and muscle weakness of a person and to make a frailty syndrome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	10 meter walking test
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	taking 60mg/day AOSs for 12 weeks
Interventions/Control_2	taking placebo for 12 weeks
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	Male
Key inclusion criteria	Pre-flail
Key exclusion criteria	People with high blood pressure
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ryoji Middle name Last name Hirota
Organization	Matsumoto university
Division name	Department of Nutrition
Zip code	3901295
Address	2095-1, Niimura, Matsumoto, Nagano
TEL	0263487200
Email	ryoji.hirota@t.mastu.ac.jp

Public contact
Name of contact person	1st name Yumiko Middle name Last name Fujioka
Organization	Matsumoo university
Division name	Department of Nutrition
Zip code	3901295
Address	2095-1, Niimura, Matsumoto, Nagano
TEL	0263487200
Homepage URL
Email	ryoryo2003@yahoo.co.jp

Sponsor
Institute	Matsumoo university
Institute
Department

Funding Source
Organization	Matsumoo university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Matsumoo university

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

IRB Contact (For public release)
Organization	Matsumoto.univ.
Address	2095-1, Niimura, Matsumoto, Nagano
Tel	0263487200
Email	ryoji.hirota@t.matsu.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	松本大学

Other administrative information
Date of disclosure of the study information	2022 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
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	Open public recruiting
Date of protocol fixation	2021 Year 04 Month 14 Day
Date of IRB	2021 Year 03 Month 29 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 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 12 Month 05 Day
Last modified on	2021 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052817