UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023852 |
|---|---|
| Receipt number | R000027478 |
| Scientific Title | Evaluation of a jelly-type functional food on the bone and cartilage metabolism in athletes |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2017/03/08 11:23:55 |
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Basic information
Public title
Evaluation of a jelly-type functional food on the bone and cartilage metabolism in athletes
Acronym
Evaluation of a jelly-type food on the bone and cartilage metabolism
Scientific Title
Evaluation of a jelly-type functional food on the bone and cartilage metabolism in athletes
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Isao Nagaoka |
Organization
Juntendo University
Division name
Graduate School of Medicine
Zip code
Address
2-1-1, Hongo, Bunkyou-ku, Tokyo, 113-0033 Japan
TEL
+81-3-5802-1033
nagaokai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akifumi Tsuruta |
Organization
Juntendo University
Division name
Graduate School of Medicine
Zip code
Address
2-1-1, Hongo, Bunkyou-ku, Tokyo, 113-0033 Japan
TEL
+81-3-5802-1033
Homepage URL
a-tsuruta@frad-consulting.name
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027478
