UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038821
Receipt number R000044261
Scientific Title Effects of 5-aminolevulinic acid supplementation on stress in healthy workers
Date of disclosure of the study information 2019/12/07
Last modified on 2022/12/09 10:18:37

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Basic information

Public title

Effects of 5-aminolevulinic acid supplementation on stress in healthy workers

Acronym

Effects of 5-aminolevulinic acid supplementation on stress in healthy workers

Scientific Title

Effects of 5-aminolevulinic acid supplementation on stress in healthy workers

Scientific Title:Acronym

Effects of 5-aminolevulinic acid supplementation on stress in healthy workers

Region

Japan


Condition

Condition

healthy workers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effects of 5-aminolevulinic acid intake on stress in healthy workers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

stress VAS(visual analog scale)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

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

5-aminolevulinic acid intake
washout period
Placebo intake

Interventions/Control_2

placebo intake
washout period
5-aminolevulinic acid 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

25 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1.25-70age
2.Continuous worker over 6-monthes (over 30-hours per week)
3.Subjects with no physical disease and no psychiatric disorder
4.Subjects with no exercise habit
5.Subjects who want to participated in the study voluntarily and who agreed to participate.

Key exclusion criteria

1.History of psychiatric disorders
2.Above 16 CES-D score(Center for Epidemiologic Studies Depression Scale)
3.Subjects who are pregnant,breastfeeding
4.Subjects with photosensitivity(porphyria)
5.Subjects who are taking foods containing St.John's Wort
6.Subjects participated in other clinical trials within 3-monthes, or planning to participate in others during this study
7.Subjects judged by the investigator as inappropriate

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Suzuki

Organization

Aoba-kokoro-no Clinic

Division name

director

Zip code

1700002

Address

2F 1-3-22, Sugamo, Toshima-ku, Tokyo, Japan

TEL

03-5981-0556

Email

suzukiaoba@ybb.ne.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Suzuki

Organization

Aoba-Promotion Co.,Ltd.

Division name

investigator

Zip code

1700002

Address

411 1-11-2, Sugamo, Toshima-ku, Tokyo, Japan

TEL

03-5976-0556

Homepage URL


Email

aoba@jtrc-tokyo.com


Sponsor or person

Institute

Aoba-Promotion Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

SBI Pharmaceuticals Co., Ltd.

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

MINS Specified Nonprofit Corporation

Address

401 5-20-9, MIta, Minato-ku, Tokyo, Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.com


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

2019 Year 12 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

Open public recruiting

Date of protocol fixation

2019 Year 11 Month 20 Day

Date of IRB

2019 Year 11 Month 20 Day

Anticipated trial start date

2019 Year 12 Month 08 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2022 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 12 Month 07 Day

Last modified on

2022 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name