UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029042 |
|---|---|
| Receipt number | R000033215 |
| Scientific Title | Effects of 5-aminolevulinic acid supplementation during exercise training on improvements of physical fitness and lifestyle related diseases. |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2017/09/07 12:44:56 |
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Basic information
Public title
Effects of 5-aminolevulinic acid supplementation during exercise training on improvements of physical fitness and lifestyle related diseases.
Acronym
Combined effects of exercise training and 5-aminolevulinic acid supplementation
Scientific Title
Effects of 5-aminolevulinic acid supplementation during exercise training on improvements of physical fitness and lifestyle related diseases.
Scientific Title:Acronym
Combined effects of exercise training and 5-aminolevulinic acid supplementation
Region
| Japan |
Condition
Condition
lifestyle related diseases
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effects of interval walking training + 5-aminolevulinic acid supplementation on the symptoms of lifstyle related diseases and methylation of pro-inflammatory genes in middle aged and older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical fitness (peak aerobic capacity, muscle strength, muscle volume), blood glucose control capacity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
5-aminolevulinic acid supplementtion(ALA). Subjects consumed a tablet of ALA(25mg) before breakfast and dinner every day for a month. The total amount of the supplement is 50mg/day.
Interventions/Control_2
placebo supplementation. Subjects consumed a tablet of dexitrin (25mg) before breakfast and dinner every day for a month. The total amount of the supplement is 50mg/day.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who participated in the health promotion program for middle-aged and older citizens in Matsumoto and who suffer from life style related diseases, showing two of the following symptoms; systolic blood pressure is no less than 130mmHg, diastolic blood pressure is no less than 85 mmHg, or BMI is no less than 25kg/m2.
2) Those who can walk.
3) Those who show no alergic reaction to 5-aminolevulinic acid.
4) Those who agree to paricipate in the study after face to face explanation about the study by investigators and give their iformed consent.
Key exclusion criteria
1) Those who do not clear the criteria above stated.
2) Those who a chief investigator judges inapproprite to participate in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizue Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2681
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University
Division name
Graduate School of Medicine
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
Institute
Department
Personal name
Funding Source
Organization
Ministru of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 09 | Month | 07 | 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
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | 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
| 2017 | Year | 09 | Month | 07 | Day |
Last modified on
| 2017 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033215
