Clinical trial NCT02295878: The Effect of Seaweed Derived Polyphenols on Inflammation and Oxidative Stress in Vivo - The SWAFAX Study
Official title: Seaweed Derived Anti-inflammatory Agents and Antioxidants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University of Reading
First posted: 2014-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: DNA damage in lymphocytes (Comet assay)
timeFrame: 8 weeks
Secondary outcomes:
measure: Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)
timeFrame: 8 weeks
Other outcomes:
measure: C-reactive protein
timeFrame: 8 weeks
measure: Oxidative stress using isoprostanes
timeFrame: 8 weeks
measure: Total cholesterol
timeFrame: 8 weeks
measure: HDL cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
Locations:
Study officials:
affiliation: Ulster University
name: Chris Gill, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.