UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050042 |
|---|---|
| Receipt number | R000056884 |
| Scientific Title | The effect of Chlorella AL-0015 to improve sleep quality. |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/04/06 00:27:55 |
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Basic information
Public title
The effect of Chlorella AL-0015 to improve sleep quality.
Acronym
The effect of Chlorella AL-0015 to improve sleep quality.
Scientific Title
The effect of Chlorella AL-0015 to improve sleep quality.
Scientific Title:Acronym
The effect of Chlorella AL-0015 to improve sleep quality.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of continued consumption of the test food on sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective sleep assessment (Athens Insomnia Scale (AIS), Pittsburgh Sleep Questionnaire (PSQI)), VAS for fatigue, heart rate analysis during sleep (BITAS-Health care)
Key secondary outcomes
Psychological assessment of stress (POMS2), urinalysis (general urine analysis, creatinine and 8-OHdG), salivary hormone analysis (cortisol and sIgA), blood tests (common hematology and biochemistry tests)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test foods for 8 weeks.
Interventions/Control_2
Intake of placebo foods for 8 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Those who are dissatisfied or anxious about their sleep.
(2)Men and women who are at least 20 years old and less than 65 years old (at the time of consent) at the time of obtaining written consent to participate in the study.
(3)Persons who have the necessary comprehension to consent to all tests, observations, and evaluation items specified in the study protocol, and who are able to obtain written consent based on their understanding of the contents of the study.
(4)Persons who are deemed appropriate by the investigator to participate in this study.
Key exclusion criteria
(1) Those who currently suffer from some chronic disease and are receiving drug treatment.
(including psychoneurological disorders)
(2)Persons who may show severe allergic symptoms to foods.
(3) Those who are pregnant or may become pregnant.
(4)Persons who are participating in other human clinical trials or have participated in other human clinical trials within 3 months
(5)Persons who consume excessive amounts of alcohol
(6)Those who are unable to participate in the study due to hepatic, renal, or cardiac disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes mellitus, or other diseases.
(7) Other subjects who are judged by the investigator to be inappropriate for the study.
(8)Those whose working hours vary greatly from day to day.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Himeno |
Organization
Medical Corporation Yutoku Hossinkai
Division name
Himeno Tomomi Clinic
Zip code
141-0032
Address
4F Win No.2 Gotanda Building, 4-1-2 Osaki, Shinagawa-ku, Tokyo
TEL
03-5436-7351
tomomi@himeno-clinic.com
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Shiono |
Organization
Algalbio Co., Ltd.
Division name
Business Development Group
Zip code
277-0882
Address
301 Tokatsu Techno Plaza, 5-4-6 Kashiwanoha, Kashiwa-shi, Chiba
TEL
04-7138-6207
Homepage URL
shiono@algalbio.co.jp
Sponsor or person
Institute
Medical Corporation Yutoku Hossinkai
Institute
Department
Personal name
Funding Source
Organization
Algalbio 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
Himeno Tomomi Clinic Ethics Committee
Address
4F Win No.2 Gotanda Building, 4-1-2 Osaki, Shinagawa-ku, Tokyo
Tel
03-5436-7351
htc.ijika@himeno-clinic.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
| 2023 | Year | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056884
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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