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

NCT02469285 | Completed

• 1 other identifier: KarniMari-HY
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Fatty acids; Lipids; Nitroso compounds; Lipid metabolism; Gut metabolism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Changes in plasma lipids as a measure of dietary modification

  4 weeks

• Concentration of polyphenolics in fecal water as a measure of consumption of berries

  4 weeks

• Change in hemoglobin as a measure of dietary modification

  4 weeks

• Change in blood pressure as a measure of dietary modofcation

  4 weeks

• Weight development during the study period

  4 weeks

Study Arms (3)

Modified pork

EXPERIMENTAL

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

Normal pork

ACTIVE COMPARATOR

Normal pork 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited

Dietary Supplement: Pork

Normal pork and berries

EXPERIMENTAL

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

Interventions

Modified pork DIETARY_SUPPLEMENT

Pork with modified fatty acid composition

Also known as: Pork with modified fatty acid composition and berries, Pork, Pork and Finnish berries

Modified pork

Pork DIETARY_SUPPLEMENT

Pork with normal fat composition

Normal pork

Pork and berries DIETARY_SUPPLEMENT

Pork with normal fat composition and Finnish berries

Normal pork and berries

Eligibility Criteria

• Age: 20 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diet includes meat

You may not qualify if:

• high consumption of fish (4 times per week)
• use of fish oil/ omega-3 oil capsules one month before the intervention
• hypercholesterolemia
• vegetarian, vegan

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Division of Nutrition, University of Helsinki

Helsinki, 00790, Finland

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Pork Meat; Fruit

Intervention Hierarchy (Ancestors)

Red Meat; Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: June 11, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

FI (1)