UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050300 |
|---|---|
| Receipt number | R000057274 |
| Scientific Title | Examination of the effects of consumption of test foods on renal function |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/08/16 10:11:00 |
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Basic information
Public title
Examination of the effects of consumption of test foods on renal function
Acronym
Examination of the effects of consumption of test foods on renal function
Scientific Title
Examination of the effects of consumption of test foods on renal function
Scientific Title:Acronym
Examination of the effects of consumption of test foods on renal function
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate exploratory the effects of test food on renal function in adults between 35 and 80 years of age when consumed for 12 consecutive weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary renal function markers (albumin)
Key secondary outcomes
Renal damage function markers in blood
Urinary renal damage function markers
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
Take one sachet (3 g) of test food daily for 12 weeks.
Interventions/Control_2
Take one sachet (3 g) of placebo daily 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
| 35 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2.Japanese who are 35 years old or more and under 80 years old at the time of consent
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons whose urinary albumin level are higher at screening
3.Persons who are allergic to the test food
4.Persons who regularly consume large amounts of the test food.
5.Persons who regularly use medicines or health foods (food for specified health uses, food with functional claims, and food with nutrient function claims) that may affect renal function.
6.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
7.Persons who were judged as inappropriate for study participants by the supervising research physician and the principal investigator
8.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Ide |
Organization
Macromill, Inc.
Division name
Life Science Department
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo
TEL
0120-998-017
Homepage URL
human@macromill.com
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Macromill, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 02 | Month | 10 | 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
70
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
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057274
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
