UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to investigate systemic absorption of health food: a cross over study
Title of the study (Brief title)	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	Sadao Mori
Organization	MORINAGA&CO., LTD.
Division name	Health Business Headquarters. R&D Department Reserch Planning Group
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	Shigeru Imai
Organization	CROee.INC
Division name	Evidence Division
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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