UMIN-CTR Clinical Trial

Basic information
Public title	A study of mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
Acronym	A study of mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
Scientific Title	A randomized, doble-blind, placebo-controlled parallel study to consider the mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
Scientific Title:Acronym	A study of mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality in human
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Melatonin Oxidative stress marker Activity meter Body Temperature Blood flow
Key secondary outcomes	Questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Prevention
Type of intervention	Food
Interventions/Control_1	Test material: Food containing aged garlic extract Duration: 4 weeks Dose: 5g/day
Interventions/Control_2	Test material: Placebo Duration: 4 weeks Dose: 5g/day
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 20 to less than 75 years old. 2) Subjects who are capable of understanding the study, and those who can give written informed consents.
Key exclusion criteria	1) Subjects who are allergic to products related to the test material of this study. 2) Subjects who are addicted to alcohol or has an extremely irregular dietary habit. 3) Subjects who take drugs, quasi-drugs, dietary supplements, health foods or something other which possibly have effects on this study. 4) Patients with diseases which apparently induce fatigue. 5) Subjects who are pregnant or breastfeeding, or desires to get pregnant during the study period. 6) Subjects who are judged unsuitable for this study by principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masataka Middle name Last name Saito
Organization	Kagawa Nutrition University
Division name	Laboratory of Food Science and Technology
Zip code	350-0288
Address	3-9-21 Chiyoda, Sakado, Saitama, Japan
TEL	049-282-3729
Email	msaito@eiyo.ac.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Nagata
Organization	Momoya Co., Ltd.
Division name	Research & Development Division
Zip code	344-8522
Address	410 Akanuma, Kasukabe, Saitama, Japan
TEL	048-720-8352
Homepage URL
Email	y.nagata@momoya.co.jp

Sponsor
Institute	Momoya 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	Kagawa Nutrition University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagawa Nutrition University Institutional Review Board
Address	3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan
Tel	049-289-6041
Email	kenshien@eiyo.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	女子栄養大学（埼玉県） Kagawa Nutrition University (Saitama) 株式会社桃屋（埼玉県） Momoya Co., Ltd. (Saitama)

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	34
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	2020 Year 11 Month 04 Day
Date of IRB	2020 Year 11 Month 18 Day
Anticipated trial start date	2020 Year 11 Month 19 Day
Last follow-up date	2021 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 29 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048270