UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026928 |
|---|---|
| Receipt number | 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 10:54:02 |
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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
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
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030702
