UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039458 |
|---|---|
| Receipt number | 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 12:58:23 |
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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
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
a-yama@kwuc.ac.jp
Sponsor or person
Institute
Kyushu Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044990
