UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037726 |
|---|---|
| Receipt number | R000043025 |
| Scientific Title | A study to investigate the efficacy of Euglena supplementation on health-related quality of life in healthy adults |
| Date of disclosure of the study information | 2019/08/19 |
| Last modified on | 2020/08/25 09:55:13 |
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Basic information
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
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
info@miura-cl.jp
Public contact
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
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
euglena 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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
0661355200
mterashima@miura-cl.jp
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 | 08 | Month | 19 | 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 | 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
Other related information
Management 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
