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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Modified pork
* Dietary Supplement: Pork
* Dietary Supplement: Pork and berries


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified pork<br>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<br>* Pork with modified fatty acid composition<br>* Other names: Pork and Finnish berries;|
| Active Comparator: Normal pork<br>Normal pork 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited | Dietary Supplement: Pork<br>* Pork with normal fat composition<br>|
| Experimental: Normal pork and berries<br>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<br>* Pork with normal fat composition and Finnish berries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma fatty acids as a measure of dietary fatty acid modification |  | 4 weeks | 
| Change in fecal nitroso compounds as a measure of increased (processed) red meat consumption | Measured as apparent total nitroso compounds (ATNC) | 4 weeks | 
| Genotoxicity testing of human fecal water in 3D cell culture | 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 | 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 | 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 |  | 4 weeks | 
| Change in blood pressure as a measure of dietary modofcation | Blood pressure is measured before and after the study period. | 4 weeks | 
| Weight development during the study period | The subjects are weighed before and after the study and their weight is monitored weekly during the study | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatty acids, Lipids, Nitroso compounds, Lipid metabolism, Gut metabolism