Unique ID issued by UMIN | UMIN000045192 |
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Receipt number | R000051627 |
Scientific Title | Effect on immunity by taking enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria: a randomized, double blind, placebo-controlled study |
Date of disclosure of the study information | 2021/08/23 |
Last modified on | 2023/03/29 10:18:39 |
Effect on immunity by taking enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria
OM-X immunity study
Effect on immunity by taking enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria: a randomized, double blind, placebo-controlled study
Effect on immunity by taking enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria
Japan |
Healthy adult
Adult |
Others
NO
Effect of test article intake on immunity
Efficacy
Subjective evaluation
QOL scale
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Take the test article for 12 weeks
Take the placebo for 12 weeks
40 | years-old | <= |
60 | years-old | > |
Male and Female
Subjects who often suffer from colds, those who are more likely to get sick than before
1.Subjects with food allergies
2.Pregnant women, lactating women, and those who are planning to become pregnant during the test period
3.Subjects who are currently going to the hospital or receiving a doctor's prescription due to chronic illness
4.Subjects who have a serious illness
5.Subjects who are receiving hormone replacement therapy
6.Subjects who have been diagnosed with chronic fatigue (chronic fatigue syndrome)
7.Subjects who are taking supplements / medicines that affect the effect of the test product
36
1st name | Masatomo |
Middle name | |
Last name | Najima |
Japan Clinical Trial Association
N.A.
1600022
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
0364574666
info@yakujihou.org
1st name | Takeshi |
Middle name | |
Last name | Kaneko |
Japan Clinical Trial Association
N.A.
1600022
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
0364574666
info@yakujihou.org
Japan Clinical Trial Association
BIOBANK CO., LTD.
Profit organization
Institutional Review Board of Pharmaceutical Law Wisdoms
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
0364574911
master@yakujihou.net
NO
2021 | Year | 08 | Month | 23 | Day |
https://isom.ca/article/immunomodulating-effect-of-om-x-fermented-plant-extract/
Published
https://isom.ca/article/immunomodulating-effect-of-om-x-fermented-plant-extract/
39
As for SF-8, 5 items out of 10 increased significantly in Active, though the Placebo showed a significant decrease in GH. In addition, intergroup analysis depicted significant differences in 6 items . With reference to physical condition, lassitude and sum total of symptoms in Active, and nasal congestion in Placebo showed significant differences after 12 weeks of ingestion. There were significant differences between the two groups in nasal congestion, lassitude, and the sum total of symptoms.
2023 | Year | 03 | Month | 29 | Day |
A group: n=19
B group: n=20
Of the 40 subjects who enrolled, 39 completed the study. There was a high level of adherence to the study protocol, with all subjects consuming their assigned test food, The data obtained from 39 subjects (Group A; 19, Group B; 20) were used for efficacy analysis. The subjects were 50.7 +- 4.8 years of age. There were no significant differences in gender ratio or age at baseline between groups.
none
Subjective evaluation (physical condition)
QOL scale (SF-8)
Completed
2021 | Year | 04 | Month | 16 | Day |
2021 | Year | 08 | Month | 11 | Day |
2021 | Year | 08 | Month | 23 | Day |
2021 | Year | 11 | Month | 15 | Day |
2021 | Year | 08 | Month | 18 | Day |
2023 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051627
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