UMIN-CTR Clinical Trial

Public title

A study to investigate the efficacy of Euglena supplementation on health-related quality of life in healthy adults

Acronym

A study to investigate the efficacy of Euglena supplementation on health-related quality of life in healthy adults

Scientific Title

A study to investigate the efficacy of Euglena supplementation on health-related quality of life in healthy adults

Scientific Title:Acronym

A study to investigate the efficacy of Euglena supplementation on health-related quality of life in healthy adults

Region

Japan

Condition

healthy individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to verify the impact of test food intake on quality of life.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Subjective index
Autonomic nerve activity index

Key secondary outcomes

Cortisol in saliva
S-IgA in saliva
Serum BDNF
Uchida-Kraepelin test
NK cell activity

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of study food (containing related ingredients 500mg ) for 12 weeks

Interventions/Control_2

Ingestion of study food (containing related ingredients 1000mg ) for 12 weeks

Interventions/Control_3

Ingestion of study food (containing related ingredients 3000mg ) for 12 weeks

Interventions/Control_4

Ingestion of control food substance for 12 weeks

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Subjects of men and women aged 20 to 64
(2) Subjects who suffer from decreased motivation
(3) Subjects who suffer from a drop in quality of sleep
(4) Subjects who received a sufficient explanation of the purpose and contents of the study, an ability to consent, a volunteer who volunteered to participate with a good understanding and who agreed to participate in the study

Key exclusion criteria

(1) Subjects with liver disease, kidney disease, digestive system disease, heart disease, peripheral angiopathy and others who have a medical history that may affect the results of this test, or subjects who have a history of surgery
(2) Subjects who show abnormal liver function and kidney function test values
(3) Subjects who have a disease currently being treated
(4) Subjects taking warfarin
(5) Subjects with food and drug allergy
(6) Subjects who have a history of mental disorder (such as depression)
(7) Subjects who work at night or irregular working hours
(8) Subjects with anemic symptoms
(9) Those who do intense sports and subjects on diet
(10) Subjects who can not quit the intake of health food (including food for FOSHU and Foods with Function Claims') and designated quasi-drugs during the test period
(11) Subjects who are taking medication (OTC drugs, including prescription drugs) continuously
(12) Those who consume too much alcohol or can not drink alcohol from 2 days before the test until the day
Test subjects
(13) Subjects who are pregnant or who are planning pregnancy or breastfeeding during the study period
(14) Subjects participating in or planning to participate in other clinical trials at the start of this study
(15) Subjects judged by the investigator as inappropriate

Target sample size

80

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

5300044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

0661355200

Email

info@miura-cl.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

5300044

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

0648018917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

euglena Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Miura Clinic, Medical Corporation Kanonkai IRB

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

Tel

0661355200

Email

mterashima@miura-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

08

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2019

Year

07

Month

10

Day

Date of IRB

2019

Year

06

Month

27

Day

Anticipated trial start date

2019

Year

08

Month

22

Day

Last follow-up date

2019

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

08

Month

19

Day

Last modified on

2020

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043025