UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055819 |
|---|---|
| Receipt number | R000063800 |
| Scientific Title | A study to verify the effect of taking Seabuckthorn juice on sleep quality |
| Date of disclosure of the study information | 2024/11/10 |
| Last modified on | 2024/10/12 15:24:40 |
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Basic information
Public title
A study to verify the effect of taking Seabuckthorn juice on sleep quality
Acronym
A study to verify the effect of taking Seabuckthorn juice on sleep quality
Scientific Title
A study to verify the effect of taking Seabuckthorn juice on sleep quality
Scientific Title:Acronym
A study to verify the effect of taking Seabuckthorn juice on sleep quality
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effect of taking Saji juice on sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of sleep quality as measured by a sleep EEG (sleep stage duration and percentage of total sleep time, sleep efficiency)
Key secondary outcomes
Sleep quality as assessed by the OSA sleep evaluation form, PSQI questionnaire, VAS questionnaire
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of Seabuckthorn juice
Interventions/Control_2
Intake of Placebo juice
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) Healthy men and women aged between 20 and 65 years old at the time of obtaining consent to participate in the study
(2) Those who are mainly desk workers and are aware of minor sleep quality issues such as being easily fatigued, having difficulty falling asleep, or having shallow sleep
(3) Those who have regular bedtimes (lights out) and wake-up times, with bedtimes (lights out) generally before 12 midnight, and who have a sleep habit of at least 4 hours per day
(4) Those who work five days a week during the day and have two days off a week
(5) Those who sleep alone in their own bed
(6) Those who can give their written consent to participate in the trial voluntarily
(7) Those who are deemed suitable for participation in the trial by the principal investigator (or the person in charge of conducting the trial)
Key exclusion criteria
(1) Those who have been diagnosed with insomnia
(2) Those who have suspected sleep apnoea syndrome (SAS), are currently being treated
(5) Those who regularly use medicines, health foods, foods for specified health uses, or foods with functional claims that may affect sleep
(6
(8) Those who work in a job type that corresponds to physical labour
(9) Those who work night shifts or work in a day/
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryujit |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-, Kashiwara-city, Osaka, Japan
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Nibun |
Organization
EAS Inc.
Division name
Clinical Trial Session
Zip code
236-0028
Address
Susaki-cho 1-10-2F, Kanazawa-ku, Yokohama, kanagawa
TEL
045-228-5243
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
Finess Co, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Finess 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
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2024 | Year | 11 | Month | 10 | 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
| 2024 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063800
