NCT02295878

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

November 3, 2014

Last Update Submit

November 17, 2014

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • DNA damage in lymphocytes (Comet assay)

    To assess the DNA damage in lymphocytes using the Comet assay

    8 weeks

Secondary Outcomes (1)

  • Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)

    8 weeks

Other Outcomes (5)

  • C-reactive protein

    8 weeks

  • Oxidative stress using isoprostanes

    8 weeks

  • Total cholesterol

    8 weeks

  • +2 more other outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

400mg capsule containing seaweed extract (treatment)

Dietary Supplement: Treatment capsule containing seaweed extract (treatment)

Placebo

PLACEBO COMPARATOR

400mg capsule containing maltodextrin (placebo)

Dietary Supplement: Placebo

Interventions

Treatment capsule containing seaweed extract (treatment)DIETARY_SUPPLEMENT

400mg capsule containing seaweed extract (treatment)

Treatment
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Non-smoker
  • Omnivores and vegetarians
  • Aged 30-65 years
  • BMI \>25kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30321272DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Therapeutics

Study Officials

  • Chris Gill, BSc, PhD

    Ulster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 20, 2014

Study Start

August 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2013

Last Updated

November 20, 2014

Record last verified: 2014-11