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

Ulster University

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Treatment capsule containing seaweed extract (treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT02295878

REC/11/0077

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

400mg capsule containing seaweed extract (treatment)

Treatment:

Dietary Supplement: Treatment capsule containing seaweed extract (treatment)

Placebo

Placebo Comparator group

Description:

400mg capsule containing maltodextrin (placebo)

Treatment:

Dietary Supplement: Placebo