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

Primary Purpose

Antioxidant Status, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pork meat from pigs feed with a standard feed.
Pork meat from pigs fed a feed with a Laminarin/fucoidan mix
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Antioxidant Status, Inflammation focused on measuring Seaweed, Pork, Fucoidan, Laminarin, Functional Food, Antioxidant activity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Human Intervention Studies Unit, Ulster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Treatment 1

Treatment 2

Arm Description

Pork meat from pigs feed with a standard feed

Pork meat from pigs fed a feed with a Laminarin/fucoidan mix

Outcomes

Primary Outcome Measures

Change in antioxidant status
Plasma Ferric Reducing Antioxidant Power

Secondary Outcome Measures

Change in protection against DNA damage
Lymphocyte DNA damage prior to and following an oxidative challenge with hydrogen peroxide.
Change in serum lipid profile
Change in plasma inflammatory status
C-reactive protein

Full Information

First Posted
February 10, 2016
Last Updated
February 10, 2016
Sponsor
University of Ulster
Collaborators
University College Dublin, University College Cork
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1. Study Identification

Unique Protocol Identification Number
NCT02682017
Brief Title
Effect of Consuming Pork From Seaweed Extract Fed Animals on Antioxidant Status
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
University College Dublin, University College Cork

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antioxidant Status, Inflammation
Keywords
Seaweed, Pork, Fucoidan, Laminarin, Functional Food, Antioxidant activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Placebo Comparator
Arm Description
Pork meat from pigs feed with a standard feed
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
Pork meat from pigs fed a feed with a Laminarin/fucoidan mix
Intervention Type
Other
Intervention Name(s)
Pork meat from pigs feed with a standard feed.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pork meat from pigs fed a feed with a Laminarin/fucoidan mix
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in antioxidant status
Description
Plasma Ferric Reducing Antioxidant Power
Time Frame
Baseline + 4 weeks
Secondary Outcome Measure Information:
Title
Change in protection against DNA damage
Description
Lymphocyte DNA damage prior to and following an oxidative challenge with hydrogen peroxide.
Time Frame
Baseline + 4 weeks
Title
Change in serum lipid profile
Time Frame
Baseline + 4 weeks
Title
Change in plasma inflammatory status
Description
C-reactive protein
Time Frame
Baseline + 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Human Intervention Studies Unit, Ulster University
City
Coleraine
State/Province
Co.Londonderry
ZIP/Postal Code
BT52 1SA
Country
United Kingdom

12. IPD Sharing Statement

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

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