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OpenTrials
Completed

NCT Number: NCT02469285

The Effect of Pork With Modified Fat Composition and Berries on Plasma Fatty Acids and 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.

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Key information

Age range

20 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Nutrition, University of Helsinki

Helsinki, 00790, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified pork

Dietary Supplement

Pork with modified fatty acid composition

Other names: Pork with modified fatty acid composition and berries, Pork, Pork and Finnish berries

Pork

Dietary Supplement

Pork with normal fat composition

Pork and berries

Dietary Supplement

Pork with normal fat composition and Finnish berries

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2015
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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