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

Seaweed Derived Anti-inflammatory Agents and Antioxidants

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Treatment capsule containing seaweed extract (treatment)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	C-reactive protein measured on an iLAB 600 analyser	8 weeks
Oxidative stress using isoprostanes	Oxidative stress will be assessed using isoprostanes	8 weeks
Total cholesterol	Total cholesterol measured in plasma on an iLAB 600 analyser	8 weeks
HDL cholesterol	HDL cholesterol measured in plasma on an iLAB 600 analyser	8 weeks
Triglycerides	Triglycerides measured in plasma on an iLAB 600 analyser	8 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: University of Reading
• Investigators: Principal Investigator: Chris Gill, BSc, PhD, Ulster University

Publications and helpful links

General Publications

• Baldrick FR, McFadden K, Ibars M, Sung C, Moffatt T, Megarry K, Thomas K, Mitchell P, Wallace JMW, Pourshahidi LK, Ternan NG, Corona G, Spencer J, Yaqoob P, Hotchkiss S, Campbell R, Moreno-Rojas JM, Cuevas FJ, Pereira-Caro G, Rowland I, Gill CIR. Impact of a (poly)phenol-rich extract from the brown algae Ascophyllum nodosum on DNA damage and antioxidant activity in an overweight or obese population: a randomized controlled trial. Am J Clin Nutr. 2018 Oct 1;108(4):688-700. doi: 10.1093/ajcn/nqy147.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: REC/11/0077