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

Study Overview
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Brief Summary
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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.

Official Title
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Seaweed Derived Anti-inflammatory Agents and Antioxidants

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Treatment capsule containing seaweed extract (treatment)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>400mg capsule containing seaweed extract (treatment) | Dietary Supplement: Treatment capsule containing seaweed extract (treatment)<br>* 400mg capsule containing seaweed extract (treatment)<br>|
| Placebo Comparator: Placebo<br>400mg capsule containing maltodextrin (placebo) | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA damage in lymphocytes (Comet assay) | To assess the DNA damage in lymphocytes using the Comet assay | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracellular cytokine analysis (Tissue Factor expression using flow cytometry) | To assess intracellular cytokine levels in lymphocyte and monocyte populations and Tissue Factor expression using flow cytometry | 8 weeks |