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NCT Number: NCT02295878

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment capsule containing seaweed extract (treatment)

Dietary Supplement

400mg capsule containing seaweed extract (treatment)

Placebo

Dietary Supplement

Primary outcomes

  1. DNA damage in lymphocytes (Comet assay)

    Time frame: 8 weeks

    To assess the DNA damage in lymphocytes using the Comet assay

Secondary outcomes

  1. Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)

    Time frame: 8 weeks

    To assess intracellular cytokine levels in lymphocyte and monocyte populations and Tissue Factor expression using flow cytometry

Other outcomes

  1. C-reactive protein

    Time frame: 8 weeks

    C-reactive protein measured on an iLAB 600 analyser

  2. Oxidative stress using isoprostanes

    Time frame: 8 weeks

    Oxidative stress will be assessed using isoprostanes

  3. Total cholesterol

    Time frame: 8 weeks

    Total cholesterol measured in plasma on an iLAB 600 analyser

  4. HDL cholesterol

    Time frame: 8 weeks

    HDL cholesterol measured in plasma on an iLAB 600 analyser

  5. Triglycerides

    Time frame: 8 weeks

    Triglycerides measured in plasma on an iLAB 600 analyser

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • University of Reading

Registry information

Official study title

Seaweed Derived Anti-inflammatory Agents and Antioxidants

Acronym: SWAFAX

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 20, 2014
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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