Unique ID issued by UMIN | UMIN000019451 |
---|---|
Receipt number | R000022407 |
Scientific Title | Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation |
Date of disclosure of the study information | 2015/10/23 |
Last modified on | 2016/11/24 15:36:29 |
Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation
Effect of Daily Ingestion of Saccharina sculpera on Immune Activation
Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation
Effect of Daily Ingestion of Saccharina sculpera on Immune Activation
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To prove the clinical benefits of daily ingestion of Saccharina sculpera on immune activation for 8 weeks.
Efficacy
Others
Pragmatic
Not applicable
Natural Killer cell activity at 4 and 8 weeks after ingestion of test meals.
leukocyte differential count, IgM,IgA,IL-12,IL-2,IFN-gamma, flow cytometric lymphocyte subset analysis, VAS scores for fatigue, etc. and defecation frequency
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
Treatment
Food |
Ingestion of 4 capsules containing powdered Saccharina sculpera 0.8g daily for 8 weeks.
Ingestion of 4 capsules containing dextrin daily for 8 weeks.
35 | years-old | <= |
65 | years-old | > |
Male and Female
1.Subjects who have relatively low NK cell activity.
2.Subjects who agree to participate in the current clinical trial with a written informed consent.
1.Subjects who are under treatment or medication for chronic inflammatory diseases, autoimmune diseases, allergies or thyroid disorders.
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine or metabolic disorders, or affected with infectious diseases which is required to report to the authorities.
3.Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries.
4.Pre- or post-menopausal women having complaints of obvious physical changes.
5.Subjects with unusually high and/or low blood pressure, and/or with abnormal hematological data.
6.Subjects with serious anemia.
7.Subjects with a history of allergy to medicine or food (especially seaweeds and gelatin).
8.Subjects who regularly take medicines, functional food or supplements (mushrooms, seaweed, nucleic acids, yeast, lactobacillus, etc.) which would affect the immune function,
9.Heavy smokers, alcohol addicts or subjects with irregular lifestyle
10.Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood component(s) within 2 weeks prior to this study
11.Subjects who are pregnant or expected to be pregnant, or lactating during the study.
12.Subjects who participate in other clinical trials within the last one month prior to this study.
13.Any other medical reasons judged by the principal investigator.
48
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Northern Advancement Center for Science & Technology
Non profit foundation
Japan
NO
北海道情報大学 保健センター(北海道)
2015 | Year | 10 | Month | 23 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 10 | Month | 30 | Day |
2016 | Year | 01 | Month | 20 | Day |
2016 | Year | 03 | Month | 04 | Day |
2016 | Year | 03 | Month | 11 | Day |
2016 | Year | 11 | Month | 17 | Day |
2015 | Year | 10 | Month | 22 | Day |
2016 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022407
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |