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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028354
Receipt No. 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

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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
Email 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
Email imai@croee.com

Sponsor
Institute CROee.INC
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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