UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004684
Receipt number R000005576
Scientific Title Effects of ingesting 5-aminolaevulinic acids (ALA) on cardiovascular, respiratory, and metabolic function during exercise
Date of disclosure of the study information 2010/12/08
Last modified on 2014/07/08 10:18:39

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Basic information

Public title

Effects of ingesting 5-aminolaevulinic acids (ALA) on cardiovascular, respiratory, and metabolic function during exercise

Acronym

Ingestion of ALA and physiological functions during exercise

Scientific Title

Effects of ingesting 5-aminolaevulinic acids (ALA) on cardiovascular, respiratory, and metabolic function during exercise

Scientific Title:Acronym

Ingestion of ALA and physiological functions during exercise

Region

Japan


Condition

Condition

none

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examin effects of ALA ingestion on physiological functions during exercise in humans.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ALA ingestion will suppress an increase in blood lactate concentration, resulting in attenuating enhanced ventilation during graded 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

Prevention

Type of intervention

Food

Interventions/Control_1

100g/day of ALA ingestion for 1 week-> placebo

Interventions/Control_2

placebo -> 100g/day of ALA ingestion for 1 wee

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy and non-smoking males whoes participation is voluntary.

Key exclusion criteria

a patient with disease and smoker

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nose, MD, PhD

Organization

Graduate School of Medicine, Shinshu University

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 Yoshi-ichiro Kamijo

Organization

Graduate School of Medicine, Shinshu University

Division name

Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2682

Homepage URL


Email

yoshikmj@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention, Shinshu University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

Organization

Division

Category of Funding 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

2010 Year 12 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2010 Year 12 Month 07 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 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

2010 Year 12 Month 08 Day

Last modified on

2014 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name