UMIN-CTR Clinical Trial

Basic information
Public title	The effect of soy peptide intake on sarcopenia and cognitive decline: A randomized controlled trial
Acronym	The effect of soy peptide intake on physical and cognitive functions
Scientific Title	The effect of soy peptide intake on sarcopenia and cognitive decline: A randomized controlled trial
Scientific Title:Acronym	The effect of soy peptide intake on physical and cognitive functions
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of soy peptide on physical and cognitive functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of correct answers on nueropsychological tests skeletal muscle index grip strength Timed & Up Go Test
Key secondary outcomes	Blood parameter

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intervention group: soy peptide containing drink 190g, 3 months
Interventions/Control_2	Control group: non-intake of soy peptide containing drink
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Elderly adults who have participated in cohort studies 2. Independent person in their activities of daily living and do not utilize Japan's long-term care service
Key exclusion criteria	1. Patient with dementia 2. Patient with severe cardiac, pulmonary, neurological or musculoskeletal disorders 3. Patient with food, and/or specifically soy allergy
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Itsushi Middle name Last name Takai
Organization	Osaka University of Economics
Division name	Department of Human Sciences
Zip code	533-8533
Address	2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533 Japan
TEL	06-6328-2431
Email	takai@osaka-ue.ac.jp

Public contact
Name of contact person	1st name Itsushi Middle name Last name Takai
Organization	Osaka University of Economics
Division name	Department of Human Sciences
Zip code	533-8533
Address	2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533 Japan
TEL	06-6328-2431
Homepage URL
Email	takai@osaka-ue.ac.jp

Sponsor
Institute	Osaka University of Economics
Institute
Department

Funding Source
Organization	Fuji Oil Co. Ltd.,
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Fuji Oil Co. Ltd.,
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Human Ethics Committee, Osaka University of Economics
Address	2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533 Japan
Tel	06-6328-2431
Email	kenkyuu@osaka-ue.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 08 Month 05 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	97
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	2018 Year 07 Month 03 Day
Date of IRB	2018 Year 08 Month 22 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2021 Year 12 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 07 Month 27 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051373