UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037200
Receipt number R000042408
Scientific Title A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being
Date of disclosure of the study information 2019/07/03
Last modified on 2019/11/13 17:11:14

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Basic information

Public title

A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being

Acronym

A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being

Scientific Title

A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being

Scientific Title:Acronym

A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being

Region

Japan


Condition

Condition

Healthy individuals

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the dose response of Euglena for improving subjective well-being depending on the amount of Euglena intake.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Questionnaires for subjective
well-being or other QOL scales

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

7

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of study food (containing related ingredients 500mg ) for 4 weeks

Interventions/Control_2

Ingestion of study food (containing related ingredients 700mg ) for 4 weeks

Interventions/Control_3

Ingestion of study food (containing related ingredients 1,000mg ) for 4 weeks

Interventions/Control_4

Ingestion of study food (containing related ingredients 1,500mg ) for 4 weeks

Interventions/Control_5

Ingestion of study food (containing related ingredients 2,000mg ) for 4 weeks

Interventions/Control_6

Ingestion of study food (containing related ingredients 3,000mg ) for 4 weeks

Interventions/Control_7

Ingestion of control food substance for 4 weeks

Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)Subjects of both sexes above 20 years old- under 65 years old
2)Subjects who can answer on line questionnaires by smartphone or iPhone
3)Subjects who give consent

Key exclusion criteria

1)Subjects who are under pharmacological treatment for chronic disorders, especially subjects who take Warfarin
2)Subjects who have histories of mental disorders (Depression etc.)
3)Subjects work irregular hours on the night shift or irregular shift
4)Subjects who had participated in other clinical trials or monitoring studies within 1 month
5)Subjects who have intolerance to study food substance
6)Subjects who are in pregnancy, lactation, or who are willing to become pregnant
7)Subjects who are ineligible due to the chief inspector's judgment

Target sample size

210


Research contact person

Name of lead principal investigator

1st name Ayaka
Middle name
Last name Nakashima

Organization

euglena Co., Ltd.

Division name

Advanced Technology Research Department Functionality Research Section

Zip code

108-0014

Address

Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan

TEL

03-3453-4907

Email

nakashima@euglena.jp


Public contact

Name of contact person

1st name shigeru
Middle name
Last name imai

Organization

Leverage Brain Inc.

Division name

Clinical Trial Department

Zip code

153-0053

Address

Gohongi 3-13-16 Meguro-ku, Tokyo 153-0053, Japan

TEL

08072900404

Homepage URL

https://www.levbrain.com

Email

imai@levbrain.com


Sponsor or person

Institute

Leverage Brain Inc.

Institute

Department

Personal name



Funding Source

Organization

euglena Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Conference of Clinical Research

Address

2-27-17 Minamiikebukuro Toshima-ku, Tokyo, Japan

Tel

0368687022

Email

jccr-info@cts-smo.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 07 Month 03 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

Completed

Date of protocol fixation

2019 Year 06 Month 03 Day

Date of IRB

2019 Year 06 Month 14 Day

Anticipated trial start date

2019 Year 07 Month 03 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry

2019 Year 10 Month 10 Day

Date trial data considered complete

2019 Year 10 Month 15 Day

Date analysis concluded

2019 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 06 Month 27 Day

Last modified on

2019 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042408


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name