UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039458
Receipt No. R000044990
Scientific Title Verification of anti-inflammatory, renal function-suppressing and antihypertensive effects of ingestion of low-fat soymilk in elderly people in a facility
Date of disclosure of the study information 2020/02/15
Last modified on 2020/02/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.