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

Abstract

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.

Keywords:

• seaweed
• fucoidan
• immune system
• complementary medicine
• nutraceutical

Acknowledgements

We thank Catherine Avila and Airdre Grant (NatMed-Research), who provided clinical research assistance; Dion Thompson (Centre for Phytochemistry and Pharmacology), who undertook the antioxidant testing; the Northern Rivers Pathology Unit, who undertook the safety measurements; and the participants who made it possible.

Authors’ contributions

SPM was the principal investigator and was involved in the study design, management of the clinical trial, interpretation of the results, and preparation of the manuscript. JO was the study coordinator; was involved in the study design, day-to-day management of the clinical trial, and data entry; and contributed to the manuscript. JHF was involved in study design and interpretation of results and contributed to the manuscript. LB supervised the statistical analysis, was involved in the interpretation of the results, and contributed to the manuscript. MR undertook the statistical analysis, was involved in interpretation of the results, and contributed to the manuscript. PC undertook the immune function studies, was involved in interpretation of the results, and contributed to the manuscript. HW provided botanical expertise and contributed to the manuscript. PAC provided natural products expertise and contributed to the manuscript. CM directs the laboratory where the immune studies and serum ORAC were undertaken and contributed to the manuscript.

Trial registration

Australian and New Zealand Clinical Trials Register: ACTRN12607000228482.

Disclosure

The study was sponsored by Marinova Pty Ltd under contract to Southern Cross University and performed independently by NatMed-Research. Dr Fitton is employed by Marinova Pty Ltd. Although she was involved in the study design, interpretation of results, and preparation of the manuscript, she had no interaction with any study participant, nor was she involved in the day-to-day running or management of the clinical trial. Marinova Pty Ltd paid the article-processing charge associated with the publication of this paper.