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

May 17, 2022 updated by: Anne-Maria Pajari, University of Helsinki

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland, 00790
        • Division of Nutrition, University of Helsinki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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
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
Pork with normal fat composition and Finnish berries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma fatty acids as a measure of dietary fatty acid modification
Time Frame: 4 weeks
4 weeks
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)
4 weeks
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.
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 21, 2014

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KarniMari-HY

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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