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The Effect of Seaweed Derived Polyphenols on Inflammation and Oxidative Stress in Vivo - The SWAFAX Study

Seaweed Derived Anti-inflammatory Agents and Antioxidants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02295878
Acronym
SWAFAX
Enrollment
80
Registered
2014-11-20
Start date
2011-08-31
Completion date
2013-03-31
Last updated
2014-11-20

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

Conditions

Cardiovascular Disease

Brief summary

Cardiovascular disease (CVD) is currently the leading cause of death worldwide. Epidemiologic studies have shown a diet rich in plant food protects against chronic degenerative diseases especially cardiovascular disease. Many of these studies have highlighted a potential role for phenolic compounds, which are abundant secondary plant metabolites, and which provide antioxidant and anti-inflammatory properties and are increasingly being shown to have an important role in influencing critical cell signalling pathways. A less well known, but nevertheless rich source of polyphenolic compounds is seaweed. In Ascophyllum nodosum, a common brown alga in the British Isles, polyphenols have been reported to comprise up to 14% of the dry weight of the plant. Some studies suggest that the potential antioxidant and anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive components with commercial potential for food and pharma applications. Preliminary work in our laboratory has revealed potent antioxidant activity of Ascophyllum nodosum extracts. Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design study is to investigate the biological activity of a food grade seaweed polyphenol extract in terms of reducing oxidative damage to DNA, modulation of inflammatory responses and reduction on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged 30-65 years) will be randomised to receive either a capsule containing 100mg seaweed extract or a matched placebo daily for an 8 week period, with an 8 week washout period between each treatment. Fasting blood and urine samples will be taken from each volunteer at 4 time-points during the study, at baseline and completion of the 2 treatment phases.

Interventions

DIETARY_SUPPLEMENTTreatment capsule containing seaweed extract (treatment)

400mg capsule containing seaweed extract (treatment)

DIETARY_SUPPLEMENTPlacebo

Sponsors

University of Reading
CollaboratorOTHER
University of Ulster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Non-smoker * Omnivores and vegetarians * Aged 30-65 years * BMI \>25kg/m2

Exclusion criteria

* Smokers * Pregnant/lactating women * Vegans * Diabetes mellitus, CVD * Autoimmune/inflammatory disorders * History of neoplasm * Recent acute illness * Anti-inflammatory medication * Habitual use of vitamin supplements

Design outcomes

Primary

MeasureTime frameDescription
DNA damage in lymphocytes (Comet assay)8 weeksTo assess the DNA damage in lymphocytes using the Comet assay

Secondary

MeasureTime frameDescription
Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)8 weeksTo assess intracellular cytokine levels in lymphocyte and monocyte populations and Tissue Factor expression using flow cytometry

Other

MeasureTime frameDescription
Total cholesterol8 weeksTotal cholesterol measured in plasma on an iLAB 600 analyser
C-reactive protein8 weeksC-reactive protein measured on an iLAB 600 analyser
Triglycerides8 weeksTriglycerides measured in plasma on an iLAB 600 analyser
HDL cholesterol8 weeksHDL cholesterol measured in plasma on an iLAB 600 analyser
Oxidative stress using isoprostanes8 weeksOxidative stress will be assessed using isoprostanes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026