UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single arm study to assess the efficacy and safety of high dose intake of food containing aged garlic extract on fatigue
Title of the study (Brief title)	A study of efficacy and safety of high dose intake of food containing aged garlic extract on fatigue
Region	Japan

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

Objectives
Narrative objectives1	The efficacy and safety of high doze intake of food containing aged garlic extract on fatigue in human.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Fatigue sensation : Visual Analog Scale
Key secondary outcomes	Body measuring/ Physical examination Blood test Urinalysis Physical condition diary Questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test material: Food containing aged garlic extract Duration: 4 weeks Dose: 15g/day
Interventions/Control_2
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 18 to less than 65 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 organic 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	10

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

Public contact
Name of contact person	Yuko Nagata
Organization	Momoya Co., Ltd.
Division name	Research & Development Division
Address	410 Akanuma, Kasukabe, Saitama 344-8522, Japan
TEL	048-735-6311
Homepage URL
Email	y.nagata@momoya.co.jp

Sponsor
Institute	Momoya Co., Ltd.
Institute
Department

Funding Source
Organization	Momoya Co., Ltd.
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)

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)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 13 Day
Anticipated trial start date	2017 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 12 Day
Last modified on	2018 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033277