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A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex
BACKGROUND: Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to admin...
Autores principales: | , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Dove Medical Press
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3044793/ https://www.ncbi.nlm.nih.gov/pubmed/21383915 http://dx.doi.org/10.2147/BTT.S12535 |
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author | Myers, Stephen P O’Connor, Joan Fitton, J Helen Brooks, Lyndon Rolfe, Margaret Connellan, Paul Wohlmuth, Hans Cheras, Phil A Morris, Carol |
author_facet | Myers, Stephen P O’Connor, Joan Fitton, J Helen Brooks, Lyndon Rolfe, Margaret Connellan, Paul Wohlmuth, Hans Cheras, Phil A Morris, Carol |
author_sort | Myers, Stephen P |
collection | PubMed |
description | BACKGROUND: Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to administer and has biological potential as an immune modulator. The study was undertaken as an open-label combined Phase I and II study. METHODS: Participants (n = 10) were randomized to receive the study medication at either a 100 mg (n = 5) or 1000 mg (n = 5) dose over 4 weeks. The primary outcome measurement was in vivo changes in lymphocyte subsets. The secondary outcome measures were ex vivo changes in T-lymphocyte (CD4 and CD8) activation, phagocytosis of granulocytes and monocytes, T helper 1/T helper 2 cytokines, and serum oxygen radical absorbance capacity. RESULTS: The preparation was found to be safe over the 4 weeks at both doses tested. There were no clinically relevant changes to blood measurements of hemopoietic, hepatic, or renal function. Immunomodulatory measurements showed no dose response between the two doses. The combined results from the two doses demonstrated a significant increase in cytotoxic T cell numbers and phagocytic capacity in monocytes, and a significant decrease in levels of the inflammatory cytokine interleukin 6. A separate analysis of the 100 mg dose (n = 5) alone showed a significant linear component over time (P < 0.05) for phagocytosis by both granulocytes and monocytes. CONCLUSION: The seaweed nutrient complex was safe to use when taken orally over 4 weeks. The preparation was demonstrated to have potential as an immune modulator, and this bioactivity deserves further exploration. |
format | Text |
id | pubmed-3044793 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-30447932011-03-07 A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex Myers, Stephen P O’Connor, Joan Fitton, J Helen Brooks, Lyndon Rolfe, Margaret Connellan, Paul Wohlmuth, Hans Cheras, Phil A Morris, Carol Biologics Original Research BACKGROUND: Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to administer and has biological potential as an immune modulator. The study was undertaken as an open-label combined Phase I and II study. METHODS: Participants (n = 10) were randomized to receive the study medication at either a 100 mg (n = 5) or 1000 mg (n = 5) dose over 4 weeks. The primary outcome measurement was in vivo changes in lymphocyte subsets. The secondary outcome measures were ex vivo changes in T-lymphocyte (CD4 and CD8) activation, phagocytosis of granulocytes and monocytes, T helper 1/T helper 2 cytokines, and serum oxygen radical absorbance capacity. RESULTS: The preparation was found to be safe over the 4 weeks at both doses tested. There were no clinically relevant changes to blood measurements of hemopoietic, hepatic, or renal function. Immunomodulatory measurements showed no dose response between the two doses. The combined results from the two doses demonstrated a significant increase in cytotoxic T cell numbers and phagocytic capacity in monocytes, and a significant decrease in levels of the inflammatory cytokine interleukin 6. A separate analysis of the 100 mg dose (n = 5) alone showed a significant linear component over time (P < 0.05) for phagocytosis by both granulocytes and monocytes. CONCLUSION: The seaweed nutrient complex was safe to use when taken orally over 4 weeks. The preparation was demonstrated to have potential as an immune modulator, and this bioactivity deserves further exploration. Dove Medical Press 2011 2011-02-15 /pmc/articles/PMC3044793/ /pubmed/21383915 http://dx.doi.org/10.2147/BTT.S12535 Text en © 2011 Myers et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. |
spellingShingle | Original Research Myers, Stephen P O’Connor, Joan Fitton, J Helen Brooks, Lyndon Rolfe, Margaret Connellan, Paul Wohlmuth, Hans Cheras, Phil A Morris, Carol A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
title | A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
title_full | A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
title_fullStr | A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
title_full_unstemmed | A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
title_short | A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
title_sort | combined phase i and ii open-label study on the immunomodulatory effects of seaweed extract nutrient complex |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3044793/ https://www.ncbi.nlm.nih.gov/pubmed/21383915 http://dx.doi.org/10.2147/BTT.S12535 |
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