UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038089 |
|---|---|
| Receipt number | R000043278 |
| Scientific Title | Study on effects of kamaboko containing fish-derived collagen peptide on bone metabolism |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2020/01/29 10:49:07 |
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Basic information
Public title
Study on effects of kamaboko containing fish-derived collagen peptide on bone metabolism
Acronym
Effect of kamaboko containing collagen peptide on bone metabolism
Scientific Title
Study on effects of kamaboko containing fish-derived collagen peptide on bone metabolism
Scientific Title:Acronym
Effect of kamaboko containing collagen peptide on bone metabolism
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of long-tern ingestion of kamaboko containg fish-derived collagen peptide on improvement of bone metabolism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone density
Key secondary outcomes
Body weight, Blood pressure, Serum cholesterol, Serum triglyceride, Blood glucose level, Gamma-GTP, White blood cell count, Red blood cell count, hemoglobin, Hematocrit, Platelet count, Total Bilirubin, Total protein, Albumin, Urea nitrogen, Creatinine, uric acid, Bone metabolism marker (serum BAP, urine NTx)
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
The subjects ingested the active meal for twelve weeks
Interventions/Control_2
The subjects ingested the placebo meal for twelve weeks
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female between 40 and 80 years old
2)Healthy people who are concerned about knee pain and bone health (Women over 1 year after menopause)
3)Individuals who can refrain from over drinking and over eating during the test period
4)Individuals who understand the purpose and contents of the experiment
Key exclusion criteria
1)Individuals taking drugs, supplements and healthy foods which affect the blood glucose levels
2)Those who can not stop taking supplements or health foods that may affect bones and joints during the test period
3)Subjects who are contracting kidney and/or liver diseases
4)Those who have bone injuries or illnesses such as fractures within the past 6 months
5)Individuals with a chronic diseases
6)Those who have received hormone replacement therapy within the past 6 months
7)Smoking habit
8)Those who may cause allergic symptoms to seafood, eggs and gelatin
9)Individuals participating or intending to participate in a drug administration test
10)Individuals judged by the doctor to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ito |
Organization
University of Nagasaki
Division name
Regional Partnership Center
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
0958135216
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Seafood Processing Industry Cooperative
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Nagasaki
Address
1-1-1Manabino,Nagayo-cho,Nishisonogi-gun,Nagasaki,Japan,851-2195
Tel
0958135216
katanaka@sun.ac.jp
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
| 2019 | Year | 09 | Month | 30 | 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
36
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
| 2019 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043278
