Unique ID issued by UMIN | UMIN000042279 |
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Receipt number | R000048270 |
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 |
Date of disclosure of the study information | 2020/11/02 |
Last modified on | 2022/05/10 12:27:47 |
A study of mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
A study of mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
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
A study of mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality
Japan |
Healthy volunteer
Not applicable | Adult |
Others
NO
The mechanism of efficacy of food containing aged garlic extract on fatigue and sleep quality in human
Efficacy
Confirmatory
Pragmatic
Not applicable
Melatonin
Oxidative stress marker
Activity meter
Body Temperature
Blood flow
Questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Prevention
Food |
Test material: Food containing aged garlic extract
Duration: 4 weeks
Dose: 5g/day
Test material: Placebo
Duration: 4 weeks
Dose: 5g/day
20 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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.
40
1st name | Masataka |
Middle name | |
Last name | Saito |
Kagawa Nutrition University
Laboratory of Food Science and Technology
350-0288
3-9-21 Chiyoda, Sakado, Saitama, Japan
049-282-3729
msaito@eiyo.ac.jp
1st name | Yuko |
Middle name | |
Last name | Nagata |
Momoya Co., Ltd.
Research & Development Division
344-8522
410 Akanuma, Kasukabe, Saitama, Japan
048-720-8352
y.nagata@momoya.co.jp
Momoya Co., Ltd.
None
Self funding
Kagawa Nutrition University
Kagawa Nutrition University Institutional Review Board
3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan
049-289-6041
kenshien@eiyo.ac.jp
NO
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)
2020 | Year | 11 | Month | 02 | Day |
Published
34
Completed
2020 | Year | 11 | Month | 04 | Day |
2020 | Year | 11 | Month | 18 | Day |
2020 | Year | 11 | Month | 19 | Day |
2021 | Year | 11 | Month | 18 | Day |
2020 | Year | 10 | Month | 29 | Day |
2022 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048270
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