Unique ID issued by UMIN | UMIN000026387 |
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Receipt number | R000030302 |
Scientific Title | A verification study on improvements in the immune system and defecation: A randomized open trial |
Date of disclosure of the study information | 2017/03/03 |
Last modified on | 2021/05/27 11:03:35 |
A verification study on improvements in the immune system and defecation: A randomized open trial
A verification study on improvements in the immune system and defecation
A verification study on improvements in the immune system and defecation: A randomized open trial
A verification study on improvements in the immune system and defecation
Japan |
Japanese adults who are healthy or regularly see a doctor
Medicine in general | Adult |
Others
NO
To verify the effects of the test food on immune system and defecation
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. Scoring of immunological vigor
*Assess at 0 and 4 weeks after consuming
1. Immunity test
T lymphocyte age, Immunological age, T cells, CD4+T cells / CD8+T cells ratio, naive T cells, naive T cells / memory T cells ratio, B cells, NK cells, CD8+CD28+T cells, T-cell proliferation index, CD4+T cells, CD8+T cells, memory T cells
*Assess at 0 and 4 weeks after consuming
2. Subjective symptoms
a. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
b. Bristol Stool Scale
c. Bowel movement diary
d. The Likert scale method
*Above a, b, and d, assess at 0 and 4 weeks after consuming
*Above c, record when defecating
3. Saliva test
Salivary immunoglobulin A (sIgA)
*Assess at 0 and 4 weeks after consuming
4. Blood test
High-sensitive CRP, albumin, prealbumin
*Assess at 0 and 4 weeks after consuming
5. Physical examination
Muscle mass, grip strength
*Assess at 0 and 4 weeks after consuming
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Food |
Duration: 4 weeks
Test Material: Nutrient-rich liquid food
Dosage: Drink 1 pack (125 mL) for a day before breakfast
Duration: 4 weeks
Test Material: Orange juice
Dosage: Drink 1 pack (125 mL) for a day after breakfast
65 | years-old | <= |
Not applicable |
Male and Female
1. Japanese adults, who is 65 years and more, are aware of daily fatigue
2. Priority selection is made in the order of II: warning zone, III: observation zone, and IV: safety zone, in immunological grade at baseline
*However, V (sufficiently high) and I (critical zone) are excluded
1. Those who have the medical history or under the treatment of malignant tumor
2. Those who have the medical history or under the treatment of autoimmune disease
3. Those who have the medical history or under the treatment of inflammatory bowel disease
4. Those who are currently hospitalized
5. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
6. Those who eat Natto, yogurt, and food and beverage including lactic acid bacteria in daily
7. Those who are smokers
8. Those who take anti-allergic drugs
9. Currently taking supplements
10. Those who are allergic to medicines and/or the test food related products
11. Those who are pregnant, breast-feeding, and plan to become a pregnant
12. Those who had participated another clinical test for three months when you signed the informed consent form for this trial
13. Others considered as inappropriate for the study by the physician
60
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
CLINICO CO.,LTD
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2017 | Year | 03 | Month | 03 | Day |
Unpublished
Published
http://www.pieronline.jp/content/article/0386-3603/47010/97
62
Shimono T, Hoshino T, Takara T. Effects of an Oral Nutritional Supplement Drink Containing Lactobacillus paracasei MCC1849 on Improving the Immune System of Elderly People-A Randomized Open-label Trial-. Jpn Pharmacol Ther. 2019; 47(1): 97-113
2021 | Year | 05 | Month | 27 | Day |
2019 | Year | 01 | Month | 28 | Day |
Refer to the paper
Refer to the paper
Refer to the paper
Refer to the paper
Undecided
To require consultation among related companies
Completed
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 03 | Month | 04 | Day |
2017 | Year | 03 | Month | 03 | Day |
2021 | Year | 05 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030302
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