UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028354 |
|---|---|
| Receipt number | R000032455 |
| Scientific Title | A study to investigate systemic absorption of health food: a cross over study |
| Date of disclosure of the study information | 2017/07/25 |
| Last modified on | 2018/05/01 12:11:01 |
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Basic information
Public title
A study to investigate systemic absorption of health food: a cross over study
Acronym
A study for systemic absorption of health food
Scientific Title
A study to investigate systemic absorption of health food: a cross over study
Scientific Title:Acronym
A study for systemic absorption of health food
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess differences in systemic absorption after ingestion of collagen peptide-containing beverages and collagen containing food in cross over study.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood hydroxyproline AUC and Cmax
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of study food substance (Once).
Interventions/Control_2
Ingestion of control food substance(1) (Once).
Interventions/Control_3
Ingestion of control food substance(2)(Once).
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Subjects who is healthy without any medications for serious disorders.
2)Subjects who gives consent in writing with full understanding of this study aim and contents
Key exclusion criteria
1) Subjects who is potential allergy to food
2) Subjects who has difficulties to participate this study due to hepatic, kidney, cardiac disorders, breathing disorder, endocrine disorder, metabolic defect, consciousness disturbance, diabetes, and other disorders.
3) Subjects who is under medication
4) Subjects who is on health food and supplements (including foods for specified health use, foods with functions claims and foods with nutrients function claims) that potentially influence the outcome of this study (Except subjects who can pause ingesting them at the point of informed consent)
5) Subjects who is under other study or within 4 weeks of termination of other study
6) Heavy smoker and heavy drinker
7) Subjects who is ineligible for this study due to physician's judgment
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadao Mori |
Organization
MORINAGA&CO., LTD.
Division name
Health Business Headquarters. R&D Department Reserch Planning Group
Zip code
Address
2-1-1 Shimosueyoshi Tsurumi-ku ,Yokohama-Shi,Kanagawa,Japan
TEL
070-3864-8266
s-mori-ab@morinaga.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee.INC
Division name
Evidence Division
Zip code
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
CROee.INC
Institute
Department
Personal name
Funding Source
Organization
MORINAGA&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
Address
Tel
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
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 08 | 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
| 2017 | Year | 07 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032455
