UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049181 |
|---|---|
| Receipt number | R000055989 |
| Scientific Title | Effect of intake of Long pepper extract on quality of sleep. |
| Date of disclosure of the study information | 2022/10/14 |
| Last modified on | 2023/04/17 11:00:15 |
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Basic information
Public title
Effect of intake of Long pepper extract on quality of sleep.
Acronym
Effect of intake of Long pepper extract on quality of sleep.
Scientific Title
Effect of intake of Long pepper extract on quality of sleep.
Scientific Title:Acronym
Effect of intake of Long pepper extract on quality of sleep.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of intake of Long pepper extract on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep EEG
Key secondary outcomes
The evaluation of questionnaire on sleep quality
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food with Long pepper extract (for 4 consecutive days) - washout period more than 3 days - Intake of placebo food (for 4 consecutive days)
Interventions/Control_2
Intake of placebo food (for 4 consecutive days) - washout period more than 3 days - Intake of test food with Long pepper extract (for 4 consecutive days)
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 and Female
Key inclusion criteria
1. Japanese males and females aged over 20 years old at the time of informed consent.
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1.Subjects who are in an environment where bedtime sleep is disturbed (such as baby, child and pet).
2. Subjects who are taking medicines and health foods related to sleep, stress, and fatigue.
3.Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day).
4. Subjects who are midnight-shift worker or shift worker.
5.Subjects who do not have a constant bedtime (more than 3 hours).
6. Subjects who do not have a constant exercise habit (in terms of high intensity exercise).
7. Subjects who do not have a constant lifestyle (such as day and night reversal).
8. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases.
9.Subjects who have chronic diseases and take medicine on a daily basis.
10. Subjects who are said to snore frequently during the night, and those who are often awakened by snoring.
11.Subjects who are smoker.
12.Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators.
13.Subjects who are pregnant or breast-feeding or have the will of pregnancy during the test period.
14.Subjects who may have an allergic reaction to the test food, and subjects who may have a severe allergic reaction to other foods or medicines.
15.subjects who plan to go on a business trip (domestic or overseas) or trip (domestic or overseas) during the study period.
16. Subjects who change their sleeping environment.
17. Subjects who participate in other clinical trials, who have participated in other clinical tests within one month of obtaining consent, or who are willing to participate.
18. Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | MOTOKO |
| Middle name | |
| Last name | TAKAOKA |
Organization
Kobe College
Division name
School of Human Sciences, Department of Biosphere Sciences
Zip code
6628506
Address
4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
TEL
0798-51-8668
takaoka@mail.kobe-c.ac.jp
Public contact
Name of contact person
| 1st name | MOTOKO |
| Middle name | |
| Last name | TAKAOKA |
Organization
Kobe College
Division name
School of Human Sciences, Department of Biosphere Sciences
Zip code
6628506
Address
4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
TEL
0798-51-8668
Homepage URL
takaoka@mail.kobe-c.ac.jp
Sponsor or person
Institute
Kobe College
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kobe College
IRB Contact (For public release)
Organization
Kobe college school of human sciences research ethics committee
Address
4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
Tel
0798-51-8423
sumi@mail.kobe-c.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
神戸女学院大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 14 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055989
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| Registered date | File name |
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