UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023431 |
|---|---|
| Receipt number | R000026998 |
| Scientific Title | A study for evaluating the effect of the combined intake of GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum on sleep: randomized, placebo-controlled, double blind traial, cross-over study |
| Date of disclosure of the study information | 2016/08/02 |
| Last modified on | 2019/06/12 13:39:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study for evaluating the effect of the combined intake of GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum on sleep: randomized, placebo-controlled, double blind traial, cross-over study
Acronym
A study for evaluating the effect of the combined intake of GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum on sleep
Scientific Title
A study for evaluating the effect of the combined intake of GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum on sleep: randomized, placebo-controlled, double blind traial, cross-over study
Scientific Title:Acronym
A study for evaluating the effect of the combined intake of GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum on sleep
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effect of the combined intake of GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum on quality of sleep, stress and mental fatigue for those who are possibly exposed to a problem with sleep, for 1 week, compared to placebo group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of EEG during sleep (Mesurement time: before and after the intake of the sample)
Key secondary outcomes
-Sleep, Stress, and Mental Fatigue: VAS
-Sleep: OSA
-Sleep: PSQI-j
(Mesurement time: before and after the intake of the sample)
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 containing GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum once a day for 1 week
Interventions/Control_2
Intake of placebo without GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum once a day for 1 week
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) Males and females from 20 to 65 years of age
2) PSQI-j score is 6 points or more
Key exclusion criteria
1) Subjects who routinely use food supplements or medicine containing GABA, extract of Hemerocallis fulva, and extract of Apocynum venetum.
2) Subjects who take care for the improvement of mental fatigue, quality of sleep and stress.
3) Subjects who have been diagnosed for and who are under any medical treatment.
4) Subjects who have history of the medical treatment and who are under the medical treatment for diabetes, liver disease, kidney disease, or heart disease.
5) Subjects who are planning to become pregnant and who are lactating.
6) Subjects who are judged as unsuitable for the study by doctor for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Horie |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development Department
Zip code
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-394-8605
k-horie@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Utano Nakamura |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development Department
Zip code
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-394-8605
Homepage URL
u-nakamura@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
FH01140020201
Org. issuing International ID_1
Nihonbashi-egawa clinical research ethical review committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社ファーマフーズ
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 02 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2017 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026998
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
