- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02682017
Effect of Consuming Pork From Seaweed Extract Fed Animals on Antioxidant Status
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Co.Londonderry
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Coleraine, Co.Londonderry, United Kingdom, BT52 1SA
- Human Intervention Studies Unit, Ulster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Age 18-55 years
- Non smoking
- BMI of < 18.5 or > 30 kg/m2.
Exclusion Criteria:
- 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
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Treatment 1
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.
|
|
Experimental: Treatment 2
Pork meat from pigs fed a feed with a Laminarin/fucoidan mix
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in antioxidant status
Time Frame: Baseline + 4 weeks
|
Plasma Ferric Reducing Antioxidant Power
|
Baseline + 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in protection against DNA damage
Time Frame: Baseline + 4 weeks
|
Lymphocyte DNA damage prior to and following an oxidative challenge with hydrogen peroxide.
|
Baseline + 4 weeks
|
|
Change in serum lipid profile
Time Frame: Baseline + 4 weeks
|
Baseline + 4 weeks
|
|
|
Change in plasma inflammatory status
Time Frame: Baseline + 4 weeks
|
C-reactive protein
|
Baseline + 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/11/0080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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