UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053583 |
|---|---|
| Receipt number | R000061144 |
| Scientific Title | Study of Inhibition of Salt Absorption in Foods Containing Plant Derived Extracts |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/13 16:58:46 |
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Basic information
Public title
Study of Inhibition of Salt Absorption in Foods Containing Plant Derived Extracts
Acronym
Study of Inhibition of Salt Absorption in Foods Containing Plant Derived Extracts
Scientific Title
Study of Inhibition of Salt Absorption in Foods Containing Plant Derived Extracts
Scientific Title:Acronym
Study of Inhibition of Salt Absorption in Foods Containing Plant Derived Extracts
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of Inhibition of Salt Absorption in Foods Containing Plant Derived Extracts
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in urinary sodium
Key secondary outcomes
Changes in blood sodium
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Plant-derived extracts
Interventions/Control_2
Placebo
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Japanese males between the ages of 20 and 60 years at the time of consent
(2) BMI between 18.5 kg/m2 and 25.0 kg/m2 at screening
(3) Systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 100 mmHg at screening
(4) Those who agree to participate in the study and are able to sign and date the consent form themselves
Key exclusion criteria
(1) Participants with a history of serious medical history or surgical resection of the digestive tract (excluding appendicectomy and endoscopic polypectomy)
(2) Participants with diseases affecting excretion, digestion and absorption, or those who are aware of various symptoms of indigestion, constipation, diarrhea, etc. on a daily basis
(3) Participants with a history of treatment for pre-existing abnormalities in renal function, liver function, blood pressure level, glucose or lipid metabolism
(4) Participants who are taking oral drugs or supplements on a regular basis
(5) Heavy alcohol drinkers (>60g of pure alcohol/day) and excessive smokers (>20 cigarettes/day) (including those who are unable to quit smoking during the clinic visit time frame or those who are unable to maintain mental and physical health by quitting smoking)
(6) Participants who are participating or will participate in an interventional trial involving the intake of other foods or drugs, or the application of cosmetics or quasi-drugs.
(7) Participants who work late at night (22:00-5:00) or work overtime for a long period of time.
(8) Participants who have donated 400 mL of blood within 6 months prior to this study.
(9) Participants who have food allergies or dislike foods, including the test food and the standardized meal.
(10) Participants who may not be able to consume ingredients whose origin is not specified in the test food due to religious or other reasons.
(11) Participants who are otherwise judged by the investigator to be inappropriate to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | masaya |
| Middle name | |
| Last name | tsubokawa |
Organization
FANCL Research Institute
Division name
clinical trial group
Zip code
2440806
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
TEL
045-820-3659
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | masaya |
| Middle name | |
| Last name | tsubokawa |
Organization
FANCL Research Institute
Division name
clinical trial group
Zip code
2440806
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
TEL
045-820-3659
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
Yamazaki Otorhinolaryngology Clinic Ethics Review Committee
Address
Kita 11-jo Nishi 14-1-16, Chuo-ku, Sapporo, Hokkaido
Tel
011-757-3387
i-takehara@kyowa-t.com
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
| 2024 | Year | 03 | Month | 01 | 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
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061144
| 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 |
