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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026928
Receipt No. R000030702
Scientific Title Effect of fish oil supplement on physical fitness and bone metabolism
Date of disclosure of the study information 2017/04/11
Last modified on 2018/04/13

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Basic information
Public title Effect of fish oil supplement on physical fitness and bone metabolism
Acronym Fish oil and physical fitness and bone metabolism
Scientific Title Effect of fish oil supplement on physical fitness and bone metabolism
Scientific Title:Acronym Fish oil and physical fitness and bone metabolism
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effects of 12-week intake of fish oil (DHA) on physical fitness and bone metabolism with randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone metabolism (urinary type I collagen cross-linked N-telopeptides)
Key secondary outcomes Physical fitness (aerobic capacity, balance ability, mobile speed, etc.)
Risk factors of life-style related disease

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
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 in DHA group take in DHA supplement 3 tablets per day in addition to performing home-based exercise using a bench step.
Interventions/Control_2 The subjects in MBP group take in MBP supplement 1 tablet per day in addition to performing home-based exercise using a bench step.
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
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Healthy elderly people aged over-sixties who has no limitation of exercise.
Key exclusion criteria Any medical conditions that contraindicated exercise, such as cardiovascular disease and orthopedic disease, etc.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Ohta
Organization Fukuoka Women's University
Division name International College of Arts and Sciences
Zip code
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL 092-661-2411
Email m-ohta@fwu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Ohta
Organization Fukuoka Women's University
Division name International College of Arts and Sciences
Zip code
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL 092-661-2411
Homepage URL
Email m-ohta@fwu.ac.jp

Sponsor
Institute Fukuoka Women's University
Institute
Department

Funding Source
Organization Fukuoka Women's University
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
Address
Tel
Email

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
2017 Year 04 Month 11 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
There was a significant increase in the bone mineral in DHA group.
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
2017 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 07 Day
Last follow-up date
2017 Year 07 Month 12 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 10 Month 13 Day
Date analysis concluded
2018 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 10 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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