UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059358 |
|---|---|
| Receipt number | R000067664 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of continuous ingestion of Euglena gracilis EOD-1 strain on sleep |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/09 16:52:36 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of continuous ingestion of Euglena gracilis EOD-1 strain on sleep in healthy adult men and women
Acronym
The effect of ingestion of Euglena gracilis EOD-1 strain on sleep
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of continuous ingestion of Euglena gracilis EOD-1 strain on sleep
Scientific Title:Acronym
The effect of ingestion of Euglena gracilis EOD-1 strain on sleep
Region
| Japan |
Condition
Condition
Healthy adult men and women aged 20 to 69
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of continuous intake of Euglena gracilis EOD-1 strain on sleep in healthy adult men and women for three weeks in a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Others
Basic objectives -Others
1. Physical measurements: height, weight, BMI (all transcribed from health checkups, etc.)
2. Actigraphy: sleep onset latency, number of awakenings, total sleep time, sleep efficiency
3. OSA Sleep Questionnaire MA version (Japan Sleep Improvement Council): A psychological scale assessing sleep reflection upon waking
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep efficiency measured by actigraphy
Key secondary outcomes
1) Sleep onset latency measured by actigraphy
2) Number of awakenings measured by actigraphy
3) Five-factor OSA-MA questionnaire completed upon waking
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Two capsules containing 500 mg of microcrystalline cellulose instead of Euglena gracilis EOD-1 strain will be taken after dinner once a day for three weeks.
Interventions/Control_2
Two capsules containing 500 mg of Euglena gracilis EOD-1 strain will be taken after dinner once a day for three weeks.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals
Ages 20 and over and 69 and under
Those who are aware of their sleep problems
Key exclusion criteria
1. Subjects with a history of or current respiratory, digestive, hepatobiliary, pancreatic, hematological, renal, endocrine, or cardiovascular disease.
2. Subjects with a history of serious trauma or surgery within 12 weeks prior to the start of the study.
3. Subjects with a history or suspected food or drug allergies requiring treatment.
4. Subjects who, during the subject explanation, the principal investigator or co-researcher determines are regularly using supplements or health foods related to sleep quality.
5. Subjects who, during the subject explanation, the principal investigator or co-researcher determines are taking actions aimed at improving sleep, fatigue, or stress.
6. Subjects who experience nighttime awakenings due to nocturnal urination, etc.
7. Subjects who have been diagnosed with sleep apnea syndrome or chronic fatigue syndrome.
8. Subjects who are allergic to the test food.
9. Subjects who have participated in other clinical trials (including clinical trials) within 4 weeks prior to the start of the study.
Other subjects who the principal investigator determines are unsuitable as subjects.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357,Japan
TEL
+81-3-5275-6048
s-aoe@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357,Japan
TEL
+81-3-5275-6048
Homepage URL
s-aoe@otsuma.ac.jp
Sponsor or person
Institute
Seiichiro Aoe
Otsuma Women's University
Faculty of Home Economics, Department of Food Science
Institute
Department
Personal name
Funding Source
Organization
Kobelco Eco-Solutions 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
Otsuma Women's UniversityLife Science Research Ethics Committee
Address
12-Sanban-cho, Chiyoda-ku, Tokyo 102-8357 Japan
Tel
+81-3-5275-6048
s-aoe@otsuma.ac.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
| 2025 | Year | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067664
