UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of a jelly-type functional food on the bone and cartilage metabolism in athletes
Title of the study (Brief title)	Evaluation of a jelly-type food on the bone and cartilage metabolism
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of a jelly-type functional food on the bone and cartilage metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A biomarker of cartilage metabolism (CTX-II)
Key secondary outcomes	A biomarker of cartilage metabolism (CPII) Biomarkers of bone metabolism (BAP, NTx) Muscle functional and physical/mental status(VAS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	16 weeks administration of a jelly-type functional food(180g/pack/day)
Interventions/Control_2	16 weeks administration of a jelly-type placebo food(180g/pack/day)
Interventions/Control_3
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	18 years-old <=
Age-upper limit	23 years-old >=
Gender	Male
Key inclusion criteria	1) Subjects giving written informed consent 2) Students of Juntendo University, who belong to sports clubs
Key exclusion criteria	1) Seriously or progressive ill patients 2) Subjects who have an allergy to shellfish or soy 3) Subjects who were judged as unsuitable for this study by the doctor for other reasons
Target sample size	44

Research contact person
Name of lead principal investigator	Isao Nagaoka
Organization	Juntendo University
Division name	Graduate School of Medicine
Address	2-1-1, Hongo, Bunkyou-ku, Tokyo, 113-0033 Japan
TEL	+81-3-5802-1033
Email	nagaokai@juntendo.ac.jp

Public contact
Name of contact person	Akifumi Tsuruta
Organization	Juntendo University
Division name	Graduate School of Medicine
Address	2-1-1, Hongo, Bunkyou-ku, Tokyo, 113-0033 Japan
TEL	+81-3-5802-1033
Homepage URL
Email	a-tsuruta@frad-consulting.name

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2017 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027478