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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024713
Receipt No. R000028431
Scientific Title A randomized, double-blind, placebo-controlled parallel study to assess the reproducibility of effects of food containing aged garlic extract on fatigue
Date of disclosure of the study information 2016/11/04
Last modified on 2017/05/08

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Basic information
Public title A randomized, double-blind, placebo-controlled parallel study to assess the reproducibility of effects of food containing aged garlic extract on fatigue
Acronym A reproducibility study of effects of food containing aged garlic extract on fatigue
Scientific Title A randomized, double-blind, placebo-controlled parallel study to assess the reproducibility of effects of food containing aged garlic extract on fatigue
Scientific Title:Acronym A reproducibility study of effects of food containing aged garlic extract on fatigue
Region
Japan

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

Objectives
Narrative objectives1 To assess the reproducibility of effects 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 POMS, Questionnaire on task performance

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test material: Food containing aged garlic extract
Duration: 8 weeks
Dose: 5g/day
Interventions/Control_2 Test material: Placebo
Duration: 8 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy males and females aged 20 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 60

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
2016 Year 11 Month 04 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
2016 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 17 Day
Last follow-up date
2017 Year 04 Month 07 Day
Date of closure to data entry
2017 Year 05 Month 20 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2017 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028431

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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