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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Treatment capsule containing seaweed extract (treatment); Dietary Supplement: Placebo

• Registration Number: NCT02295878
• Lead Sponsor: University of Ulster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-02
• Study Completion: 2013-03
• Status Verified: 2014-11
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-17
• Last Update Submitted: 2014-11-17
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	Treatment capsule containing seaweed extract (treatment)	400mg capsule containing seaweed extract (treatment)
Placebo	Placebo	400mg capsule containing maltodextrin (placebo)

Primary Outcome Measures

Name	Time	Method
DNA damage in lymphocytes (Comet assay)	8 weeks	To assess the DNA damage in lymphocytes using the Comet assay

Secondary Outcome Measures

Name	Time	Method
Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)	8 weeks	To assess intracellular cytokine levels in lymphocyte and monocyte populations and Tissue Factor expression using flow cytometry