UMIN-CTR Clinical Trial

Basic information
Public title	Verification of anti-inflammatory, renal function-suppressing and antihypertensive effects of ingestion of low-fat soymilk in elderly people in a facility
Acronym	Verification of anti-inflammatory effects and suppression of renal function decline by ingestion of low-fat soy milk in elderly people in a facility
Scientific Title	Verification of anti-inflammatory, renal function-suppressing and antihypertensive effects of ingestion of low-fat soymilk in elderly people in a facility
Scientific Title:Acronym	Verification of anti-inflammatory effects and suppression of renal function decline by ingestion of low-fat soy milk in elderly people in a facility
Region	Japan

Condition
Condition	Elderly patients hospitalized in the convalescent ward
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	he purpose of this study is to examine the nutritional status improvement, anti-inflammatory effect, and renal function-suppressing effect of low-fat soymilk intake by the elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Low fat soy milk
Interventions/Control_2	Ordinary milk
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 30 elderly people 70 years or older who are hospitalized in the convalescent ward 2) Those who can participate in the test period and who can drink soy milk continuously 3) A person who has given written consent from the person (family if dementia patient) to participate in this study
Key exclusion criteria	1) Allergic to soybean, soymilk, milk 2) Diabetic patients on medication 3) Persons taking internal medicine that affects the evaluation items 4) Others who have judged that participation in this test is inappropriate
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Yukizane
Organization	Nakagawa Hospital
Division name	Surgery
Zip code	8111345
Address	2-17-17,Mukaishinmachi, Minami-ku, Fukuoka
TEL	092-565-3531
Email	taka1956-mh1118@lion.ocn.ne.jp

Public contact
Name of contact person	1st name Ai Middle name Last name Yamamoto
Organization	Kyushu Women's University
Division name	Faculty of Home Economics
Zip code	807-8586
Address	1-1 Jiyugaoka, Yahatanishi, kitakyushu, Fukuoka
TEL	0936933332
Homepage URL
Email	a-yama@kwuc.ac.jp

Sponsor
Institute	Kyushu Women's University
Institute
Department

Funding Source
Organization	Fuji Foundation for Protein Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kyushu Women's University
Address	1-1 Jiyugaoka, Yahatanishi, kitakyushu, Fukuoka
Tel	093-693-3116
Email	soumuka@kwuc.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	2020 Year 02 Month 15 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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 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	2020 Year 02 Month 11 Day
Last modified on	2020 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044990