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.
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
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.
- Conditions
- Antioxidant Status, Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| Treatment 1 | Placebo comparator | Pork meat from pigs feed with a standard feed Receives: Other: Pork meat from pigs feed with a standard feed. |
| Treatment 2 | Experimental | Pork 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.
Change in antioxidant status
Plasma Ferric Reducing Antioxidant Power
Measured: Baseline + 4 weeks
Secondary outcomes (3)
Change in protection against DNA damage
Lymphocyte DNA damage prior to and following an oxidative challenge with hydrogen peroxide.
Measured: Baseline + 4 weeks
Change in serum lipid profile
Measured: Baseline + 4 weeks
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.
- First posted15 Feb 2016 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antioxidant Status, InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, University College Cork
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02682017
- Acronym / sponsor ID
- REC/11/0080
- Conditions
- Antioxidant Status, Inflammation
- Keywords
- Seaweed, Pork, Fucoidan, Laminarin, Functional Food, Antioxidant activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University College Dublin, University College Cork
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Feb 2016 (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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Placebo comparator | Other: Pork meat from pigs feed with a standard feed.Pork meat from pigs feed with a standard feed |
| Treatment 2 | Experimental | Other: Pork meat from pigs fed a feed with a Laminarin/fucoidan mixPork meat from pigs fed a feed with a Laminarin/fucoidan mix |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Age 18-55 years
- Non smoking
- BMI of < 18.5 or > 30 kg/m2.
Key exclusion criteria (14 listed)
- Regular consumers of seaweed (>5 g/week)
- Non-consumers of pork or pork products
- Smoker
- Pregnant and lactating women
- Vegetarians and vegans
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 |
|---|---|---|
| Pork meat from pigs feed with a standard feed.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. | Other | Treatment 1 |
| Pork meat from pigs fed a feed with a Laminarin/fucoidan mix4 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). | Other | Treatment 2 |
Primary outcome
Change in antioxidant status
Time frame: Baseline + 4 weeks
Plasma Ferric Reducing Antioxidant Power
3 secondary outcomes
Change in protection against DNA damage
Time frame: Baseline + 4 weeks
Change in serum lipid profile
Time frame: Baseline + 4 weeks
Change in plasma inflammatory status
Time frame: Baseline + 4 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 15 Feb 2016.
Related trials for Antioxidant Status, Inflammation
Not yet recruitingObservational study
Inflammation and Diabetes: Evaluating Antioxidant Levels
Diabete Mellitus, Diabete Type 2
Not yet recruiting
Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.
Inflammation Biomarkers, Cardiometabolic Health Indicators
Enrolling by invitation
Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study)
MAFLD, Fatty Liver
Active, not recruiting
Postprandial Effect of Olive Leaf Biscuits and Tea Consumption on Blood Biomarkers in Healthy Individuals
Oxidative Stress, Inflammation Biomarkers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.