A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex

Stephen P Myers1, Joan O'Connor1, J Helen Fitton2, Lyndon Brooks3, Margaret Rolfe3, Paul Connellan4, Hans Wohlmuth4,5, Phil A Cheras1, Carol Morris41NatMed-Research Unit, Research Cluster for Health and Wellbeing, Southern Cross University, Lismore, NSW, Australia; 2Marinova Pty Ltd, Cam...

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Autores principales: Stephen P Myers, Joan O'Connor, J Helen Fitton, et al
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Publicado: Dove Medical Press 2011
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spelling oai:doaj.org-article:c6c91163268e4150957e3d38914455f42021-12-02T02:28:17ZA combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex1177-54751177-5491https://doaj.org/article/c6c91163268e4150957e3d38914455f42011-02-01T00:00:00Zhttp://www.dovepress.com/a-combined-phase-i-and-ii-open-label-study-on-the-immunomodulatory-eff-a6351https://doaj.org/toc/1177-5475https://doaj.org/toc/1177-5491Stephen P Myers1, Joan O'Connor1, J Helen Fitton2, Lyndon Brooks3, Margaret Rolfe3, Paul Connellan4, Hans Wohlmuth4,5, Phil A Cheras1, Carol Morris41NatMed-Research Unit, Research Cluster for Health and Wellbeing, Southern Cross University, Lismore, NSW, Australia; 2Marinova Pty Ltd, Cambridge, TAS, Australia; 3Graduate Research College, Southern Cross University, Lismore, NSW, Australia; 4Centre for Phytochemistry and Pharmacology, Southern Cross University, Lismore, NSW, Australia; 5Medicinal Plant Herbarium, Southern Cross University, Lismore, NSW, AustraliaBackground: 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.Keywords: seaweed, fucoidan, immune system, complementary medicine, nutraceutical Stephen P MyersJoan O'ConnorJ Helen Fittonet alDove Medical PressarticleMedicine (General)R5-920ENBiologics: Targets & Therapy, Vol 2011, Iss default, Pp 45-60 (2011)
institution DOAJ
collection DOAJ
language EN
topic Medicine (General)
R5-920
spellingShingle Medicine (General)
R5-920
Stephen P Myers
Joan O'Connor
J Helen Fitton
et al
A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex
description Stephen P Myers1, Joan O'Connor1, J Helen Fitton2, Lyndon Brooks3, Margaret Rolfe3, Paul Connellan4, Hans Wohlmuth4,5, Phil A Cheras1, Carol Morris41NatMed-Research Unit, Research Cluster for Health and Wellbeing, Southern Cross University, Lismore, NSW, Australia; 2Marinova Pty Ltd, Cambridge, TAS, Australia; 3Graduate Research College, Southern Cross University, Lismore, NSW, Australia; 4Centre for Phytochemistry and Pharmacology, Southern Cross University, Lismore, NSW, Australia; 5Medicinal Plant Herbarium, Southern Cross University, Lismore, NSW, AustraliaBackground: 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.Keywords: seaweed, fucoidan, immune system, complementary medicine, nutraceutical
format article
author Stephen P Myers
Joan O'Connor
J Helen Fitton
et al
author_facet Stephen P Myers
Joan O'Connor
J Helen Fitton
et al
author_sort Stephen P Myers
title 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_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_sort combined phase i and ii open-label study on the immunomodulatory effects of seaweed extract nutrient complex
publisher Dove Medical Press
publishDate 2011
url https://doaj.org/article/c6c91163268e4150957e3d38914455f4
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