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Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on the Effect 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019451
Enrollment
48
Registered
2015-10-23
Start date
2015-10-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Ingestion of 4 capsules containing powdered Saccharina sculpera 0.8g daily for 8 weeks. Ingestion of 4 capsules containing dextrin daily for 8 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Natural Killer cell activity at 4 and 8 weeks after ingestion of test meals.

Secondary

MeasureTime frame
leukocyte differential count, IgM,IgA,IL-12,IL-2,IFN-gamma, flow cytometric lymphocyte subset analysis, VAS scores for fatigue, etc. and defecation frequency

Countries

Japan

Contacts

Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Hokkaido Information University Health Information Science Center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026