UMIN-CTR Clinical Trial

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
Email	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
Email	katanaka@sun.ac.jp

Sponsor
Institute	University of Nagasaki
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043278