Cardiovascular DiseaseSWAFAXNCT02295878
The Effect of Seaweed Derived Polyphenols on Inflammation and Oxidative Stress in Vivo - The SWAFAX Study
A study testing Treatment capsule containing seaweed extract (treatment) in people with Cardiovascular Disease, run by University of Ulster.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Treatment capsule containing seaweed extract (treatment)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Non-smoker
- Omnivores and vegetarians
- Aged 30-65 years
- BMI >25kg/m2
Who cannot join
- Smokers
- Pregnant/lactating women
- Vegans
- Diabetes mellitus, CVD
- Autoimmune/inflammatory disorders
- History of neoplasm
Show all 9Show fewer
- Recent acute illness
- Anti-inflammatory medication
- Habitual use of vitamin supplements
About this study
Official title: Seaweed Derived Anti-inflammatory Agents and Antioxidants
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Treatment capsule containing seaweed extract (treatment), Placebo
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment capsule containing seaweed extract (treatment)Dietary supplement
400mg capsule containing seaweed extract (treatment)
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 400mg capsule containing seaweed extract (treatment) Receives: Dietary Supplement: Treatment capsule containing seaweed extract (treatment) |
| Placebo | Placebo comparator | 400mg capsule containing maltodextrin (placebo) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA damage in lymphocytes (Comet assay)
To assess the DNA damage in lymphocytes using the Comet assay
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading
- Responsible party
- Principal investigator, Chris gill, University of Ulster
- Investigators
- Chris Gill, BSc, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295878
- Sponsor's protocol ID
- REC/11/0077
- Acronym
- SWAFAX
- Status last verified
- Nov 2014
- First submitted
- 3 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30321272
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seaweed Derived Anti-inflammatory Agents and Antioxidants
- ClinicalTrials.gov ID
- NCT02295878
- Acronym / sponsor ID
- SWAFAX / REC/11/0077
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Dietary Supplement: Treatment capsule containing seaweed extract (treatment)400mg capsule containing seaweed extract (treatment) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo400mg capsule containing maltodextrin (placebo) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Non-smoker
- Omnivores and vegetarians
- Aged 30-65 years
- BMI >25kg/m2
Key exclusion criteria (9 listed)
- Smokers
- Pregnant/lactating women
- Vegans
- Diabetes mellitus, CVD
- Autoimmune/inflammatory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment capsule containing seaweed extract (treatment)400mg capsule containing seaweed extract (treatment) | Dietary supplement | Treatment |
| Placebo | Dietary supplement | Placebo |
Primary outcome
DNA damage in lymphocytes (Comet assay)
Time frame: 8 weeks
To assess the DNA damage in lymphocytes using the Comet assay
1 secondary outcome
Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Derived from this study: PubMed 30321272Baldrick 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Gill, BSc, PhD principal investigator
Ulster University
Questions about this trial
What is this clinical trial studying?
A study testing Treatment capsule containing seaweed extract (treatment) in people with Cardiovascular Disease, run by University of Ulster.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA damage in lymphocytes (Comet assay) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.