- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02469285
The Effect of Pork With Modified Fat Composition and Berries on Plasma Fatty Acids and Fecal Compounds in Healthy Adults
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00790
- Division of Nutrition, University of Helsinki
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modified pork
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
|
Pork with modified fatty acid composition
Other Names:
|
Active Comparator: Normal pork
Normal pork 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited
|
Pork with normal fat composition
|
Experimental: Normal pork and berries
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
|
Pork with normal fat composition and Finnish berries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma fatty acids as a measure of dietary fatty acid modification
Time Frame: 4 weeks
|
4 weeks
|
|
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)
|
4 weeks
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
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
|
4 weeks
|
Change in hemoglobin as a measure of dietary modification
Time Frame: 4 weeks
|
4 weeks
|
|
Change in blood pressure as a measure of dietary modofcation
Time Frame: 4 weeks
|
Blood pressure is measured before and after the study period.
|
4 weeks
|
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
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KarniMari-HY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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