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The Effect of Pork With Modified Fat Composition and Berries on Plasma Fatty Acids and Fecal Compounds in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02469285
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
HKScan
Information provided by (Responsible Party):
Anne-Maria Pajari, Helsinki University

Brief Summary:

High consumption of red meat is related to cardiovascular diseases. Red meat containing more unsaturated fat than normal red meat may have a beneficial impact on plasma lipid and fatty acid profile in humans. Furthermore, consumption of red meat and especially processed red meat is considered harmful to colon health. However, consumption of fruit and berries rich in antioxidants and flavonoids may provide protection when red meat is consumed.

The study aims to answer whether the fatty acid profile of pork when modified towards more unsaturated fat will affect plasma fatty acids and lipids in adult volunteers. The effects of pork with a modified fatty acid content is compared with conventional pork with lower unsaturated fat content. Fatty acid composition of pork is modified by altering the composition of animal feed.

The other arm of the study investigates the effects of consuming berries together with red meat on gut metabolism. The study focuses on how berries affect the formation of fecal compounds known to be related to high red meat consumption, such as N-nitroso compounds.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Modified pork Dietary Supplement: Pork Dietary Supplement: Pork and berries Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Pork With Modified Fatty Acid Composition on Plasma Lipids and Fatty Acids and the Effect of Pork and Berries on Fecal Compounds in Healthy Adults
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Modified pork
Pork with modified fatty acid composition, more unsaturated fat. 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited
Dietary Supplement: Modified pork
Pork with modified fatty acid composition
Other Names:
  • Pork with modified fatty acid composition and berries
  • Pork
  • Pork and Finnish berries

Active Comparator: Normal pork
Normal pork 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited
Dietary Supplement: Pork
Pork with normal fat composition

Experimental: Normal pork and berries
Normal pork and berries (strawberry, raspberry, wild blueberry, lingonberry, cloudberry, blackcurrant) 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited
Dietary Supplement: Pork and berries
Pork with normal fat composition and Finnish berries




Primary Outcome Measures :
  1. Change in plasma fatty acids as a measure of dietary fatty acid modification [ Time Frame: 4 weeks ]
  2. Change in fecal nitroso compounds as a measure of increased (processed) red meat consumption [ Time Frame: 4 weeks ]
    Measured as apparent total nitroso compounds (ATNC)

  3. Genotoxicity testing of human fecal water in 3D cell culture [ Time Frame: 4 weeks ]
    Fecal water is isolated from fecal samples collected before and after the intervention period from arms B and C. The samples are tested for markers of genotoxicity in 3D cell culture.


Secondary Outcome Measures :
  1. Changes in plasma lipids as a measure of dietary modification [ Time Frame: 4 weeks ]
    Concentrations of and changes in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides are measured before and after the intervention period

  2. Concentration of polyphenolics in fecal water as a measure of consumption of berries [ Time Frame: 4 weeks ]
    The polyphenol content of the fecal water is assessed from arms B and C

  3. Change in hemoglobin as a measure of dietary modification [ Time Frame: 4 weeks ]
  4. Change in blood pressure as a measure of dietary modofcation [ Time Frame: 4 weeks ]
    Blood pressure is measured before and after the study period.

  5. Weight development during the study period [ Time Frame: 4 weeks ]
    The subjects are weighed before and after the study and their weight is monitored weekly during the study



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Ages Eligible for Study:   20 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diet includes meat

Exclusion Criteria:

  • high consumption of fish (4 times per week)
  • use of fish oil/ omega-3 oil capsules one month before the intervention
  • hypercholesterolemia
  • vegetarian, vegan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469285


Locations
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Finland
Division of Nutrition, University of Helsinki
Helsinki, Finland, 00790
Sponsors and Collaborators
Helsinki University
HKScan
Investigators
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Principal Investigator: Anne-Maria Pajari, PhD Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki
Principal Investigator: Marja Mutanen, PhD Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki

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Responsible Party: Anne-Maria Pajari, Adjunct professor, Helsinki University
ClinicalTrials.gov Identifier: NCT02469285     History of Changes
Other Study ID Numbers: KarniMari-HY
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Keywords provided by Anne-Maria Pajari, Helsinki University:
Fatty acids
Lipids
Nitroso compounds
Lipid metabolism
Gut metabolism

Additional relevant MeSH terms:
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Cardiovascular Diseases