UMIN-CTR Clinical Trial

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
Email	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
Email	u-nakamura@pharmafoods.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd.
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026998