UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052623 |
|---|---|
| Receipt number | R000060049 |
| Scientific Title | Blood dynamics test by ingestion of test food |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/02/25 10:44:41 |
* 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
Blood dynamics test by ingestion of test food
Acronym
Blood dynamics test
Scientific Title
Blood dynamics test by ingestion of test food
Scientific Title:Acronym
Blood dynamics test
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the transition to blood by measuring the amount of active ingredient in venous serum after ingestion of test food.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Various amino acid concentrations in venous serum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: once/day
Test food: A
Administration: From 20:00 on the previous day until the final blood sampling on the day of the test, the patient was fasted and ingested 5 g of test food A at a time.
Interventions/Control_2
Duration: once/day
Test food: B
Administration: From 20:00 on the previous day until the final blood sampling on the day of the test, the patient was fasted and ingested 5 g of test food B at a time.
Interventions/Control_3
Duration: once/day
Test food: C
Administration: From 20:00 on the previous day until the final blood sampling on the day of the test, the patient was fasted and ingested 5 g of test food C at a time.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women between the ages of 20 and 70.
2) A person who receives all explanations, agrees, and is expected to be able to complete it.
3) Those who can comply with dietary restrictions from the day before intake (collagen peptides, soy protein, whey protein, dairy products, soy products) who can provide written consent.
Key exclusion criteria
1) Pregnant / lactating
2) Those who are prone to anemia
3) Those who are continuously receiving medical treatment or medication for illness, etc.
4) Those with a history of cardiovascular disease or renal function
5) Those with nervous system diseases and metabolic disorders
6) In addition, those who are judged by the investigator to be non-conforming
7) Those who are taking medications other than the above that may affect the test results
8) Those who have already participated in other clinical trials
9) Those who take collagen every day
10) Vegans
11) Those who are allergic to the test drug (allergy label: gelatin, soybean, milk)
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Koizumi |
Organization
Nitta Gelatin Inc.
Division name
Research Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
se-koizumi@nitta-gelatin.co.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Koizumi |
Organization
Nitta Gelatin Inc.
Division name
Research Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
Homepage URL
se-koizumi@nitta-gelatin.co.jp
Sponsor or person
Institute
Nitta Gelatin Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Co-creation Association AMC Nishiumeda Clinic Research Ethics Review Committee
Address
Hotel Monterey Osaka Office Building Maruito Nishi Umeda Building 3F
Tel
06-4797-5660
morikawa@amc-clinic.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
医療法人共創会ＡＭＣ西梅田クリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060049
