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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029109
Receipt No. R000033277
Scientific Title A single arm study to assess the efficacy and safety of high dose intake of food containing aged garlic extract on fatigue
Date of disclosure of the study information 2017/09/13
Last modified on 2018/03/21

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Basic information
Public title A single arm study to assess the efficacy and safety of high dose intake of food containing aged garlic extract on fatigue
Acronym A study of efficacy and safety of high dose intake of food containing aged garlic extract on fatigue
Scientific Title A single arm study to assess the efficacy and safety of high dose intake of food containing aged garlic extract on fatigue
Scientific Title:Acronym 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
1st name
Middle name
Last name Masataka Saito
Organization Kagawa Nutrition University
Division name Laboratory of Food Science and Technology
Zip code
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
1st name
Middle name
Last name Yuko Nagata
Organization Momoya Co., Ltd.
Division name Research & Development Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 09 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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