UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024713
Receipt number 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 09:17:15

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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 or person

Institute

Momoya Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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