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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013210
Receipt No. 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

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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
Email 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
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015417

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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