UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052913 |
|---|---|
| Receipt number | R000060374 |
| Scientific Title | Evaluation of improvement of sleep quality by ingestion of a standardized extract of Asparagus officinalis stem (ETAS50) in employees and their family members of Amino Up, Co., Ltd. |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/27 15:18:44 |
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Basic information
Public title
Evaluation of improvement of sleep quality by ingestion of an asparagus stem extract (ETAS50)
Acronym
Evaluation Study of Improvement of Sleep Quality using ETAS50
Scientific Title
Evaluation of improvement of sleep quality by ingestion of a standardized extract of Asparagus officinalis stem (ETAS50) in employees and their family members of Amino Up, Co., Ltd.
Scientific Title:Acronym
Evaluation Study of Improvement of Sleep Quality using ETAS50
Region
| Japan |
Condition
Condition
Decrease in sleep quality
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of EEG during sleep in healthy subjects with sleep and sleep quality problems during ingestion of ETAS50 for improvement of sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep electroencephalogram measurement
-Sleep quality related indexes: sleep efficiency, arousal index, sleep onset latency, wake time after sleep onset
-Sleep status: lights-out time, lights-on time, total recording time, sleep-onset time, sleep-median time, final wake-up, time on the floor after final wake-up, total sleep time, sleep stage duration, sleep stage occurrence rate, and REM latency.
Key secondary outcomes
-Sleep Questionnaire: OSA-MA, Pre-Sleep Questionnaire (PSQ)
-HSP-70 expression in blood cells
-Adverse events
-Subjects' logbooks
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food or placebo intake period: 14 days in each of the first and second cycles (Test food and placebo are interchanged in the first and second cycles).
-Cycle 1: 7 days of pre-treatment and 7 days of EEG measurement.
-Cycle 2: 7 days pre-treatment period and 7 days EEG measurement period
Washout period: 14 days between Cycle 1 and Cycle 2
300 mg (as ETAS50) once daily after dinner
Interventions/Control_2
Test food or placebo intake period: 14 days in each of the first and second cycles (Test food and placebo are interchanged in the first and second cycles).
-Cycle 1: 7 days of pre-treatment and 7 days of EEG measurement.
-Cycle 2: 7 days pre-treatment period and 7 days EEG measurement period
Washout period: 14 days between Cycle 1 and Cycle 2
300 mg (as ETAS50) once daily after dinner
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
| Not applicable |
Gender
Male
Key inclusion criteria
-Healthy adult male
-Day shift workers from Monday to Friday (excluding those who work the early or late shift or other on-duty days)
-Those who are able to take oral intake adequately.
-Persons who have been fully informed of the study and who have given their free and voluntary written consent based on a thorough understanding of the study.
Key exclusion criteria
-BMI of 25 or higher (body mass index of 1 or higher) and Epworth sleepiness scale (evaluation of sleepiness) of 11 or higher.
-Those who have good sleep phase, quality, and quantity (phase: 9 points or more, quality: 11 points or more, quantity: 9 points or more) on the 3D Sleep Scale (3DSS), and who score less than 6 points for sleep disturbance on the Pittsburgh Sleep Questionnaire (PSQI-J).
-Morningness/eveningness diagnosis (morning/evening type) with a clear morningness (70-86 points) or clear eveningness (16-30 points).
-Those who have an excessive*1 smoking habit.
-Heavy drinker of alcohol*2
-Heavy drinkers*3 of caffeine-containing beverages and those who habitually consume caffeine-containing beverages within 4 hours before bedtime.
-Those who have severe anemia, circulatory disease, respiratory disease, liver disease, renal disease, gastrointestinal disease, diabetes, rheumatoid arthritis, acute infectious disease, psychiatric disease, cerebrovascular disease, benign prostatic hyperplasia, frequent urination at night, symptoms of overactive bladder, etc.
-Those who are receiving treatment for insomnia or sleep disorders.
-Persons with serious drug or food allergies
-Patients who are regularly using medications prescribed by a physician that are thought to affect sleep.
-Persons enrolled in other clinical trials.
-Other subjects deemed unsuitable by the principal investigator.
*1: More than 20 cigarettes per day on average
*2: Alcohol: An average of more than 60 g of the equivalent of pure alcohol per day, for example, 3 medium beer bottles (about 3 long cans 500 mL x 3), a little less than 3 gou of sake (180 mL x 3), 1+1/2 glasses (about 300 mL) of 25% shochu, 3 double glasses (about 180 mL) of whiskey, a little less than 6 glasses (about 600 mL) of wine, 3 cans (about 350 mL x 3) of canned chuhai with 7% alcohol
*3: Coffee: An average of more than 3 cups (237 mL/cup x 3) in a mug per day
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takanari |
Organization
AMINO UP Co., Ltd.
Division name
Business Development Division
Zip code
004-0839
Address
363-32 Shin-ei, Kiyota, Sapporo, Japan
TEL
0118892555
takanari@aminoup.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Takahashi |
Organization
AMINO UP Co., Ltd.
Division name
Business Development Division
Zip code
004-0839
Address
363-32 Shin-ei, Kiyota, Sapporo, Japan
TEL
011-889-2555
Homepage URL
ttakahashi@aminoup.jp
Sponsor or person
Institute
AMINO UP Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
AMINO UP Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Non-profit organization Hokkaido Activation Center, TACTICS
Address
Infas, Kita 2-jo Nishi 9-chome, Chuo-ku, Sapporo, Hokkaido
Tel
011-662-8591
yuriko.iw@gmail.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 | 12 | Month | 01 | 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
| 2021 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060374
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