UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051074 |
|---|---|
| Receipt number | R000058003 |
| Scientific Title | Evaluation of the blood kinetics of collagen peptide metabolites by ingestion of collagen peptides with different formulations |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/05/16 18:50:17 |
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Basic information
Public title
Evaluation of the blood kinetics of collagen peptide metabolites by ingestion of collagen peptides with different formulations
Acronym
Evaluation of the blood kinetics of collagen peptide metabolites by ingestion of collagen peptides with different formulations
Scientific Title
Evaluation of the blood kinetics of collagen peptide metabolites by ingestion of collagen peptides with different formulations
Scientific Title:Acronym
Evaluation of the blood kinetics of collagen peptide metabolites by ingestion of collagen peptides with different formulations
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the blood kinetics of collagen peptide metabolites when ingested
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood concentraion of collagen peptide metabolites before and 5, 10, 15, 30, 60 minutes after ingestion of test foods
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
To ingest HACP-TFC
Interventions/Control_2
To ingest CPF-C
Interventions/Control_3
To ingest Meta Collagen
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese males aged 20 to 59 years old at the time of informed consent
2) Subjects whose height is between 160 and 178 cm
3) Subjects whose BMI is between 22 and 25
Key exclusion criteria
1) Subjects with severe gastrointestinal, hepatic, renal, circulatory, hematologic, endocrine, or malignant neoplasm suspected or with a history of such diseases
2) Subjects who have possibility of allergy to gelatine
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nagai |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
y_nagai@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
JELLICE
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
| 2023 | Year | 05 | Month | 22 | 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
4
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
| 2022 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2023 | 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 | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058003
