UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054707 |
|---|---|
| Receipt number | R000062518 |
| Scientific Title | Random controled study for evaluate the effects of consumption of the test beverage on sleep quality |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2024/06/19 14:41:17 |
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Basic information
Public title
Random controled study for evaluate the effects of consumption of the test beverage on sleep quality
Acronym
Random controled study for evaluate the effects of consumption of the test beverage on sleep quality
Scientific Title
Random controled study for evaluate the effects of consumption of the test beverage on sleep quality
Scientific Title:Acronym
Random controled study for evaluate the effects of consumption of the test beverage on sleep quality
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of test beverage consumption on sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain waves during sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of test food A for three week (Once a day, two hours before sleep)
Interventions/Control_2
Consumption of test food B for three week (Once a day, two hours before sleep)
Interventions/Control_3
Consumption of test food C for three week (Once a day, two hours before sleep)
Interventions/Control_4
Consumption of placebo for three week (Once a day, two hours before sleep)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Males and females whose age of 40 years or more
2) Subjects capable of measuring brain waves during sleep.
Key exclusion criteria
1) Subjects receiving a medical treatment for sleep disorders
2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
3) Subjects receiving a medical treatment for chronic diseases
4) Subjects whose sleeping styles are irregular because of night shift or others
5) Subjects regularly taking medicines or Food with Functional Claims having the effects on sleep quality
6) Subjects having the possibility of developing allergic symptoms by the test food
7) Subjects who took part in another clinical study within 4 weeks prior to the start of the present study or who is currently taking part in another clinical study
8) Subjects deemed unsuitable by the investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Furushima |
Organization
Kagoshima University
Division name
School of Health Science, Faculty of medicine
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
0992756793
dfuru@health.nop.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Furushima |
Organization
Kagoshima University
Division name
School of Health Science, Faculty of medicine
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
0992756793
Homepage URL
dfuru@health.nop.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Koueki Syadanhoujin Isyokudougen Shouyaku Kenkyu Zaidan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University
Address
8-35-1, sakuragaoka, kagoshima
Tel
099-275-6091
isgskkrs@kuas.kagoshima-u.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
| 2024 | Year | 06 | Month | 19 | 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 | 04 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062518
