UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013210 |
|---|---|
| Receipt number | R000015417 |
| Scientific Title | The effects of 5-aminlevulinic acid supplementation on home-based walking training in middle-aged and older women with depressive mood |
| Date of disclosure of the study information | 2014/02/22 |
| Last modified on | 2014/02/21 14:44:19 |
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Basic information
Public title
The effects of 5-aminlevulinic acid supplementation on home-based walking training in middle-aged and older women with depressive mood
Acronym
ALA intake and walking training achievement in older women with depressive mood
Scientific Title
The effects of 5-aminlevulinic acid supplementation on home-based walking training in middle-aged and older women with depressive mood
Scientific Title:Acronym
ALA intake and walking training achievement in older women with depressive mood
Region
| Japan |
Condition
Condition
Depressive mood
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether ALA intake improves walking training achievement in older women with depressive mood.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taining achievement, Respiratory and cardiovascular responses to exercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Interval walking training
Interventions/Control_2
ALA or Placebo intake
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Middle-aged and older women visiting the Aoba Mental Clinic in Tokyo for depressive mood.
2) Those who suffer morre than two symptons of hypertension, hyperglycemia, obesity and show more than 20 points in the CES-D score.
3) Those who can perform interval walking training without physical trouble.
4) Those who want to participated in the study voluntarily.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 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
nosehir@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
SBI Pharma
Organization
Division
Category of Funding Organization
Profit 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 | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | 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 | 21 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015417
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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