UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051452 |
|---|---|
| Receipt number | R000058284 |
| Scientific Title | Comparison of the intestinal absorbance of three different types of hydrolyzed collagens: A randomized, double-blind, crossover study |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2023/11/13 09:58:56 |
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Basic information
Public title
Comparison of the intestinal absorbance of three different types of hydrolyzed collagens
Acronym
Comparison of the intestinal absorbance of three different types of hydrolyzed collagens
Scientific Title
Comparison of the intestinal absorbance of three different types of hydrolyzed collagens: A randomized, double-blind, crossover study
Scientific Title:Acronym
Comparison of the intestinal absorbance of different types of hydrolyzed collagen
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the absorption of hydrolyzed collagen after a single administration of three distinct types of collagens obtained from various sources
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of AUC (0-3h) after a single oral administration of three distinct hydrolyzed collagens
Key secondary outcomes
- Comparison of Cmax and Tmax
- Comparison of AUC, Cmax, or Tmax between males and females
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single oral administration of 5 g hydrolyzed collagen A
Interventions/Control_2
A single oral administration of 5 g hydrolyzed collagen B
Interventions/Control_3
A single oral administration of 5 g hydrolyzed collagen C
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
| 34 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy
Key exclusion criteria
1) Under medication for chronic diseases
2) Taking medicines or dietary supplements that may affect the trial
3) Participation in any clinical trial within three months of the commencement of the trial
4) Allergic to fish, cattle, or gelatin
5) In pregnancy or nursing a child
6) Judged as ineligible by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1909
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1909
Homepage URL
healthy-life@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
MTG Co., Ltd.
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058284
| 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 |
