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Antioxidant Status, InflammationNCT02682017

Effect of Consuming Pork From Seaweed Extract Fed Animals on Antioxidant Status

A study testing Pork meat from pigs feed with a standard feed. and Pork meat from pigs fed a feed with a Laminarin/fucoidan mix in people with Antioxidant Status, Inflammation, run by University of Ulster at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Red meat makes a significant contribution to the human diet. The most widely consumed meat globally is pork which accounts for 36% of overall meat intake with beef and poultry contributing 22% and 35%, respectively. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Antioxidant Status, Inflammation
What is being tested?
Pork meat from pigs feed with a standard feed. and Pork meat from pigs fed a feed with a Laminarin/fucoidan mix
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2011to Nov 2011
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy
  • Age 18-55 years
  • Non smoking
  • BMI of < 18.5 or > 30 kg/m2.

Who cannot join

  • Regular consumers of seaweed (>5 g/week)
  • Non-consumers of pork or pork products
  • Smoker
  • Pregnant and lactating women
  • Vegetarians and vegans
  • Lactose intolerant individuals
Show all 14Show fewer
  • Diabetes
  • Cardiovascular disease
  • Autoimmune/ inflammatory disorders
  • History of neoplasm
  • Recent acute illness and/or chronic prescribed or self-prescribed use of anti-inflammatory agents (including aspirin)
  • Use of broad spectrum antibiotics
  • Use of drugs active on gastrointestinal motility or laxatives
  • Use of dietary supplements (specifically probiotics or prebiotics).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Human Intervention Studies Unit, Ulster University

    Coleraine, Co.Londonderry, BT52 1SA

Other trials in United Kingdom

About this study

Official title: Effect of Consuming Pork From Animals Supplemented With Laminarin and Fucoidan Derived From the Brown Seaweed Laminaria Digitata on the Antioxidant Status of Human Participants.

Red meat makes a significant contribution to the human diet. The most widely consumed meat globally is pork which accounts for 36% of overall meat intake with beef and poultry contributing 22% and 35%, respectively. Pork meat provides a range of important nutrients including protein, zinc, B-vitamins and a range of important minerals however there is accumulating evidence to suggest that consuming red meat and processed meat increases the risk of cardiovascular disease (CVD) and colon cancer. Despite these reports of a negative impact on health, global pork consumption continues to increase and there are increasing efforts to improve the nutritional profile of pork meat through the development of novel porcine feed regimens. The manipulation of pig feed to produce 'healthier' meat and meat products offers a feasible approach to reduce the risk of preventable disease. Furthermore, recent projections of an increased global demand for pork and poultry, particularly in China, have highlighted the increasing strain that will be placed on the supply of grains and the need to find alternative and sustainable feed ingredients. Macroalgae is emerging as a potential sustainable source of novel bioactive ingredients for the animal feed industry with some species known to be a good source of protein, minerals, polyunsaturated fatty acids and a range of fibre components including fucoidan and laminarin.

The polysaccharides, laminarin and fucoidan, which are found in abundance in brown seaweed, are gaining increasing attention as a potential bioactive feed ingredients with putative antioxidant, anti-inflammatory and immunomodulatory activities. Incorporation of a laminarin/fucioidan mix (LAM/FUC) into the porcine diet was shown to result in lower levels of lipid oxidation in fresh pork steaks. Numerous studies to date have also investigated the health promoting effects of LAM/FUC through modulation of the porcine gut microbiota which was shown to enhance inflammatory cytokine expression in response to pathogen recognition and also to increase piglet performance post weaning.

Read more

The uptake and fate of fucoidan in humans remains unknown albeit after consumption, unaltered fucoidan has been detected in human plasma after ingestion suggesting at least partial bioavailability of this compound. A study by Moroney et al. (2015) using an in vitro bioavailability Caco-2 model provided indications that fucoidan was bioavailable and that it may have potent antioxidant potential.

The primary aim of this randomised parallel placebo controlled human intervention trial was to investigate if consuming pork meat from pigs supplemented with a LAM/FUC mix, in addition to their normal diet, would impact on blood oxidant and inflammatory status of healthy adults. The secondary aim was to determine the effect of consuming LAM/FUC fed pork meat on lymphocyte DNA damage, lipid status and immune function in healthy adults.

Being tested
Pork meat from pigs feed with a standard feed., Pork meat from pigs fed a feed with a Laminarin/fucoidan mix
Keywords
Seaweed, Pork, Fucoidan, Laminarin, Functional Food, Antioxidant activity
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pork meat from pigs feed with a standard feed.Other

    4 week intervention with 700g (raw weight) of pork meat (3x pork burgers (125g raw weight each) + pork mince (325 g raw weight) per week.

  • Pork meat from pigs fed a feed with a Laminarin/fucoidan mixOther

    4 week intervention with 700g (raw weight) of pork meat (3x pork burgers (125g raw weight each) + pork mince (325 g raw weight) per week from pigs fed animal feed supplemented (5.37 kg/tonne of feed) with spray-dried laminarin and fucoidan (seaweed).

Study groups in NCT02682017
Study groupRoleWhat they receive
Treatment 1Placebo comparatorPork meat from pigs feed with a standard feed
Receives: Other: Pork meat from pigs feed with a standard feed.
Treatment 2ExperimentalPork meat from pigs fed a feed with a Laminarin/fucoidan mix
Receives: Other: Pork meat from pigs fed a feed with a Laminarin/fucoidan mix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in antioxidant status

    Plasma Ferric Reducing Antioxidant Power

    Measured: Baseline + 4 weeks

Secondary outcomes (3)
  1. Change in protection against DNA damage

    Lymphocyte DNA damage prior to and following an oxidative challenge with hydrogen peroxide.

    Measured: Baseline + 4 weeks

  2. Change in serum lipid profile

    Measured: Baseline + 4 weeks

  3. Change in plasma inflammatory status

    C-reactive protein

    Measured: Baseline + 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2016 (estimated)
  2. Study startAug 2011
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02682017
Sponsor's protocol ID
REC/11/0080
Status last verified
Feb 2016
First submitted
10 Feb 2016
Last updated
15 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Pork meat from pigs feed with a standard feed. and Pork meat from pigs fed a feed with a Laminarin/fucoidan mix in people with Antioxidant Status, Inflammation, run by University of Ulster at 1 site in United Kingdom.

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 4 inclusion and 14 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change in antioxidant status (time frame: Baseline + 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Feb 2016.

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