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

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 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


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

Value
https://center6.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