The Effect of Seaweed Derived Polyphenols on Inflammation & Oxidative

Status Completed

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02295878
Study type	Interventional
Source	University of Ulster
Contact
Status	Completed
Phase	N/A
Start date	August 2011
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02122198` - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women	N/A
Completed	`NCT02502812` - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects	Phase 1
Recruiting	`NCT04216342` - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers	Phase 1
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT03646656` - Heart Health Buddies: Peer Support to Decrease CVD Risk	N/A
Completed	`NCT02081066` - Identification of CETP as a Marker of Atherosclerosis	N/A
Completed	`NCT02147626` - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia	N/A
Not yet recruiting	`NCT06405880` - Pharmacist Case Finding and Intervention for Vascular Prevention Trial	N/A
Recruiting	`NCT03095261` - Incentives in Cardiac Rehabilitation	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Completed	`NCT02589769` - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons	N/A
Completed	`NCT02711878` - Healing Hearts and Mending Minds in Older Adults Living With HIV	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Completed	`NCT02868710` - Individual Variability to Aerobic Exercise Training	N/A
Recruiting	`NCT02885792` - Coronary Artery Disease in Patients Suffering From Schizophrenia	N/A
Completed	`NCT02272946` - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk	Phase 2
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A
Completed	`NCT02657382` - Mental Stress Ischemia: Biofeedback Study	N/A
Completed	`NCT02640859` - Investigation of Metabolic Risk in Korean Adults
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms