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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029042
Receipt No. 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

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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
Email 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
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033215

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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