NIPH Clinical Trials Search

Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect of Saccharina Sculpera on Immune Activation

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	2015/10/30
Target sample size	48
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Ingestion of 4 capsules containing powdered Saccharina sculpera 0.8g daily for 8 weeks. Ingestion of 4 capsules containing dextrin daily for 8 weeks.

Outcome(s)

Primary Outcome	Natural Killer cell activity at 4 and 8 weeks after ingestion of test meals.
Secondary Outcome	leukocyte differential count, IgM,IgA,IL-12,IL-2,IFN-gamma, flow cytometric lymphocyte subset analysis, VAS scores for fatigue, etc. and defecation frequency

Key inclusion & exclusion criteria

Age minimum	35years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude criteria	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.