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

Cardiovascular Disease Clinical Trial

— SWAFAX  

Official title:

Seaweed Derived Anti-inflammatory Agents and Antioxidants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295878
• Other study ID #: REC/11/0077
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: November 17, 2014
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2014
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Treatment capsule containing seaweed extract (treatment)
400mg capsule containing seaweed extract (treatment)
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	University of Reading

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C-reactive protein	C-reactive protein measured on an iLAB 600 analyser	8 weeks	No
Other	Oxidative stress using isoprostanes	Oxidative stress will be assessed using isoprostanes	8 weeks	No
Other	Total cholesterol	Total cholesterol measured in plasma on an iLAB 600 analyser	8 weeks	No
Other	HDL cholesterol	HDL cholesterol measured in plasma on an iLAB 600 analyser	8 weeks	No
Other	Triglycerides	Triglycerides measured in plasma on an iLAB 600 analyser	8 weeks	No
Primary	DNA damage in lymphocytes (Comet assay)	To assess the DNA damage in lymphocytes using the Comet assay	8 weeks	No
Secondary	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	No