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| Name | Class |
|---|---|
| University of Reading | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 400mg capsule containing seaweed extract (treatment) |
|
| Placebo | Placebo Comparator | 400mg capsule containing maltodextrin (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment capsule containing seaweed extract (treatment) | Dietary Supplement | 400mg capsule containing seaweed extract (treatment) |
|
| Measure | Description | Time Frame |
|---|---|---|
| DNA damage in lymphocytes (Comet assay) | To assess the DNA damage in lymphocytes using the Comet assay | 8 weeks |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Gill, BSc, PhD | Ulster University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30321272 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Placebo | Dietary Supplement |
|
| 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 |