Antioxidant Status, Inflammation Clinical Trial
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.
| Verified date | February 2016 |
| Source | University of Ulster |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
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). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Human Intervention Studies Unit, Ulster University | Coleraine | Co.Londonderry |
| Lead Sponsor | Collaborator |
|---|---|
| University of Ulster | University College Cork, University College Dublin |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in antioxidant status | Plasma Ferric Reducing Antioxidant Power | Baseline + 4 weeks | No |
| Secondary | Change in protection against DNA damage | Lymphocyte DNA damage prior to and following an oxidative challenge with hydrogen peroxide. | Baseline + 4 weeks | No |
| Secondary | Change in serum lipid profile | Baseline + 4 weeks | No | |
| Secondary | Change in plasma inflammatory status | C-reactive protein | Baseline + 4 weeks | No |