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

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ClinicalTrials.gov Identifier: NCT02295878
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
University of Reading
Information provided by (Responsible Party):
Chris gill, 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Treatment capsule containing seaweed extract (treatment) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Seaweed Derived Anti-inflammatory Agents and Antioxidants
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Active Comparator: Treatment
400mg capsule containing seaweed extract (treatment)
Dietary Supplement: Treatment capsule containing seaweed extract (treatment)
400mg capsule containing seaweed extract (treatment)

Placebo Comparator: Placebo
400mg capsule containing maltodextrin (placebo)
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. DNA damage in lymphocytes (Comet assay) [ Time Frame: 8 weeks ]
    To assess the DNA damage in lymphocytes using the Comet assay


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295878


Sponsors and Collaborators
University of Ulster
University of Reading
Investigators
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Principal Investigator: Chris Gill, BSc, PhD Ulster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chris gill, Senior Lecturer, University of Ulster
ClinicalTrials.gov Identifier: NCT02295878     History of Changes
Other Study ID Numbers: REC/11/0077
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Cardiovascular Diseases