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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469285
• Other study ID #: KarniMari-HY
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2014

Study information

• Verified date: May 2022
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Modified pork
Pork with modified fatty acid composition
• Pork
Pork with normal fat composition
• Pork and berries
Pork with normal fat composition and Finnish berries

Locations

Country	Name	City	State
Finland	Division of Nutrition, University of Helsinki	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma fatty acids as a measure of dietary fatty acid modification		4 weeks
Primary	Change in fecal nitroso compounds as a measure of increased (processed) red meat consumption	Measured as apparent total nitroso compounds (ATNC)	4 weeks
Primary	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	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
Secondary	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
Secondary	Change in hemoglobin as a measure of dietary modification		4 weeks
Secondary	Change in blood pressure as a measure of dietary modofcation	Blood pressure is measured before and after the study period.	4 weeks
Secondary	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