Unique ID issued by UMIN | UMIN000013933 |
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Receipt number | R000016236 |
Scientific Title | Effects of food containing Kurozu Moromi and garlic powder on immune function : a randomized, double blind, placebo-controlled study |
Date of disclosure of the study information | 2014/05/12 |
Last modified on | 2014/11/04 17:14:29 |
Effects of food containing Kurozu Moromi and garlic powder on immune function : a randomized, double blind, placebo-controlled study
Effects of food containing Kurozu Moromi and garlic powder on immune function
Effects of food containing Kurozu Moromi and garlic powder on immune function : a randomized, double blind, placebo-controlled study
Effects of food containing Kurozu Moromi and garlic powder on immune function
Japan |
Healthy adult
Not applicable |
Others
NO
This study aims to evaluate the effects of ingestion of food containing Kurozu Moromi and garlic powder for 8 consecutive weeks on immune function in subjects with lower salivary secretory immunoglobulin A (sIgA) secretion rate.
Efficacy
Immune function (salivary sIgA secretion rate, CD4, CD8, CD4/CD8 ratio)
cytokine
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of food containing Kurozu Moromi and garlic powder for 8 consecutive weeks
Ingestion of placebo (food without Kurozu Moromi and garlic powder) for 8 consecutive weeks
30 | years-old | <= |
60 | years-old | > |
Male and Female
1) An age 30 years or older and up to 60 years
2) A lower salivary secretory immunoglobulin A secretion rate
1) Subjects who consume food containing Kurozu Moromi and garlic
2) Subjects routinely taking dietary supplements which may influence immune function
3) Subjects who has history of the allergic disease
4) Subjects who are under medication (e.g., hyposensitization) which may influence the outcome of the study
5) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care
6) Subjects who has oral or dental problems with bleeding
7) Night and day shift worker or manual laborer
8) Subjects who has carries out an intense activity (e.g., marathon race)
9) Subjects who cannot carry out a procedure of various inspection by the rule during the study period
10) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor
11) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
12) Subjects with allergies to the products used in the study
13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination
14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
17) Subjects who are judged as unsuitable for the study by the investigator for other reason
60
1st name | |
Middle name | |
Last name | 1) Norimasa Sato, 2) Takayuki Azuma |
1) Umeda Oak Clinic
2) Yaesu Sakura dori Clinic
Internal Medicine
1) 2-6-6 sonesaki, kita-ku, Osaka 2) 1-6-6 yaesu, chuo-ku, Tokyo
03-6214-1285.06-6130-8735
t-azuma@y-sakuradoori.jp
1st name | |
Middle name | |
Last name | Hiroyasu Shimada |
TTC Co., Ltd.
Clinical Research Planning Department
1-20-2 Ebisunishi, shibuya-ku, Tokyo
03-5459-5329
ttcpwr2001@ttc-tokyo.co.jp
TTC Co., Ltd.
Kenkoukazoku Co., Ltd.
Profit organization
NO
2014 | Year | 05 | Month | 12 | Day |
Unpublished
Completed
2014 | Year | 04 | Month | 16 | Day |
2014 | Year | 05 | Month | 13 | Day |
2014 | Year | 09 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
Subgroup analyses are going to be performed in immune function
(Principal investigator's E-mail adress:n-sato@umeda-oak-clinic.com)
2014 | Year | 05 | Month | 12 | Day |
2014 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016236
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