Clinical trial NCT02469285: The Effect of Pork With Modified Fat Composition and Berries on Plasma Fatty Acids and Fecal Compounds in Healthy Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Fatty acids
Lipids
Nitroso compounds
Lipid metabolism
Gut metabolism
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in plasma fatty acids as a measure of dietary fatty acid modification
timeFrame: 4 weeks
measure: Change in fecal nitroso compounds as a measure of increased (processed) red meat consumption
timeFrame: 4 weeks
measure: Genotoxicity testing of human fecal water in 3D cell culture
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in plasma lipids as a measure of dietary modification
timeFrame: 4 weeks
measure: Concentration of polyphenolics in fecal water as a measure of consumption of berries
timeFrame: 4 weeks
measure: Change in hemoglobin as a measure of dietary modification
timeFrame: 4 weeks
measure: Change in blood pressure as a measure of dietary modofcation
timeFrame: 4 weeks
measure: Weight development during the study period
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Division of Nutrition, University of Helsinki
Study officials:
affiliation: Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki
name: Anne-Maria Pajari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki
name: Marja Mutanen, PhD
role: PRINCIPAL_INVESTIGATOR
References: