UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013246 |
|---|---|
| Receipt number | R000015455 |
| Scientific Title | Combined effects of nutritional supplement (agaro-oligosaccharides) intake and exercise training on osteoarthritis and life-style related diseases in older women |
| Date of disclosure of the study information | 2014/02/25 |
| Last modified on | 2014/02/24 18:19:42 |
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Basic information
Public title
Combined effects of nutritional supplement (agaro-oligosaccharides) intake and exercise training on osteoarthritis and life-style related diseases in older women
Acronym
Combined effects of exercise and nutritional supplements
Scientific Title
Combined effects of nutritional supplement (agaro-oligosaccharides) intake and exercise training on osteoarthritis and life-style related diseases in older women
Scientific Title:Acronym
Combined effects of exercise and nutritional supplements
Region
| Japan |
Condition
Condition
Life-style related diseases and osteoarthritis
Classification by specialty
| Medicine in general | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of nutritional supplements (agaro-oligosaccharides) intake on life-style related diseases and osteo-artritis by focusing on the modification of inflammatory genes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The indice of life-style related diseases, joint pain, exercise training achievement, the modification of inflammatory genes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Nutritional summplement
Interventions/Control_2
Placebo
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Those who did not improve the symptoms of life-styke related diseases or osteoarthritis while they have achieved interval walking training more than 6 months.
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichiro Taniguchi |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Molecular Oncology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2682
stangch@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Sports Medical Sciences
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2681
Homepage URL
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research grants from the MEXT
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 02 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 04 | 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
| 2014 | Year | 02 | Month | 24 | Day |
Last modified on
| 2014 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015455
