Unique ID issued by UMIN | UMIN000043386 |
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Receipt number | R000049527 |
Scientific Title | A Study on the Effect of Plant-Derived Product on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
Date of disclosure of the study information | 2021/02/20 |
Last modified on | 2023/11/29 16:22:03 |
A Study on the Effect of Plant-Derived Product on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Study on the Effect of Plant-Derived Product on Immune Function
A Study on the Effect of Plant-Derived Product on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Study on the Effect of Plant-Derived Product on Immune Function
Japan |
No
Adult |
Others
NO
To confirm the effect of plant-derived products on immune function.
Efficacy
Salivary sIgA
Skin moisture content
Physical condition questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Plant-Derived Products, 4 weeks consumption
Placebo Products, 4 weeks consumption
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Healthy males and females aged 20 to 64 years-old.
(2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Subjects (who)
(1)have a faster salivary sIgA secretion rate.
(2)have a constipation tendency.
(3)contract diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease).
(4)have a chronic disease and regularly use medications.
(5)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions.
(6)can't stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or live bacteria during test periods.
(7)get intense exercises (e.g., muscle training in the gym) more than 3 times a week.
(8)are under treatment for periodontal disease.
(9)used antibiotics within the last two weeks prior to the screening.
(10)can't stop drinking from a day before each measurement.
(11)have declared an allergic reaction to test foods.
(12)have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(13)plan to become pregnant after informed consent, pregnant or lactating.
(14)are under treatment for or have a history of drug addiction and/or alcoholism.
(15)are shiftworker and/or midnight-shift worker.
(16)are participating and/or had participated and/or are planning to participate in other clinical studies that affect this study.
(17)with skin disease, such as atopic dermatitis.
(18)with strange skin conditions at measurement points.
(19)neglect skin care.
(20)can't avoid direct sunlight exposure, such as sunburn, during test periods.
(21)had been conducted an operation or beauty treatment on the test spot in the past 6 months.
(22)are judged unsuitable for the study by the investigator for other reasons.
40
1st name | Takayuki |
Middle name | |
Last name | Kado |
TOYO SHINYAKU Co., Ltd.
Clinical and analytical research center
841-0005
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
0942-81-3555
kadot@toyoshinyaku.co.jp
1st name | Nobutaka |
Middle name | |
Last name | Kusaba |
TOYO SHINYAKU Co., Ltd.
Clinical and analytical research center
841-0005
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
0942-81-3555
gakujutsu@toyoshinyaku.co.jp
TOYO SHINYAKU Co., Ltd.
TOYO SHINYAKU Co., Ltd.
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
06-6135-5200
mterashima@miura-cl.jp
NO
2021 | Year | 02 | Month | 20 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049527
Published
http://www.pieronline.jp/content/article/0386-3603/51070/1053
38
Statistically significant difference was confirmed in the salivary sIgA secretion rate.
2023 | Year | 11 | Month | 29 | Day |
Males and females aged 20 to 64 years old.
Enrolled(n=38)
Completed(n=37)
Analyzed(n=33)
No adverse events were observed that be related to test food.
Salivary sIgA secretion rate
Completed
2021 | Year | 02 | Month | 01 | Day |
2021 | Year | 02 | Month | 18 | Day |
2021 | Year | 03 | Month | 01 | Day |
2021 | Year | 05 | Month | 06 | Day |
2021 | Year | 02 | Month | 19 | Day |
2023 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049527
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