Cardiovascular DiseasesNCT02469285
The Effect of Pork With Modified Fat Composition and Berries on Plasma Fatty Acids and Fecal Compounds in Healthy Adults
A study testing Modified pork, Pork and Pork and berries in people with Cardiovascular Diseases, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 20 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Modified pork, Pork and Pork and berries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diet includes meat
Who cannot join
- high consumption of fish (4 times per week)
- use of fish oil/ omega-3 oil capsules one month before the intervention
- hypercholesterolemia
- vegetarian, vegan
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Modified pork, Pork, Pork and berries
- Keywords
- Fatty acids, Lipids, Nitroso compounds, Lipid metabolism, Gut metabolism
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified porkDietary supplement
Also called Pork with modified fatty acid composition and berries, Pork, Pork and Finnish berries
Pork with modified fatty acid composition
PorkDietary supplement
Pork with normal fat composition
Pork and berriesDietary supplement
Pork with normal fat composition and Finnish berries
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Pork and berries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma fatty acids as a measure of dietary fatty acid modification
Measured: 4 weeks
Change in fecal nitroso compounds as a measure of increased (processed) red meat consumption
Measured as apparent total nitroso compounds (ATNC)
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 4 weeks
Change in hemoglobin as a measure of dietary modification
Measured: 4 weeks
Change in blood pressure as a measure of dietary modofcation
Blood pressure is measured before and after the study period.
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Maria Pajari, University of Helsinki
- Investigators
- Anne-Maria Pajari, PhD, Principal investigator, Division of Nutrition, Department of Food and Environmental Sciences, University of HelsinkiMarja Mutanen, PhD, Principal investigator, Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469285
- Sponsor's protocol ID
- KarniMari-HY
- Status last verified
- May 2022
- First submitted
- 21 Dec 2014
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Onali T, Slaba H, Jian C, Koivumaki T, Paivarinta E, Marttinen M, Maattanen M, Salonen A, Pajari AM. Berry supplementation in healthy volunteers modulates gut microbiota, increases fecal polyphenol metabolites and reduces viability of colon cancer cells exposed to fecal water- a randomized controlled trial. J Nutr Biochem. 2025 Jul;141:109906. doi: 10.1016/j.jnutbio.2025.109906. Epub 2025 Mar 20.
PubMed 40120775
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02469285
- Acronym / sponsor ID
- KarniMari-HY
- Conditions
- Cardiovascular Diseases
- Keywords
- Fatty acids, Lipids, Nitroso compounds, Lipid metabolism, Gut metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified pork | Experimental | Dietary Supplement: Modified porkPork 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 |
| Normal pork | Active comparator | Dietary Supplement: PorkNormal pork 160 g pork or pork products daily for 4 weeks, consumption of other red meat is prohibited |
| Normal pork and berries | Experimental | Dietary Supplement: Pork and berriesNormal 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 |
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diet includes meat
Key exclusion criteria (4 listed)
- high consumption of fish (4 times per week)
- use of fish oil/ omega-3 oil capsules one month before the intervention
- hypercholesterolemia
- vegetarian, vegan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified porkAlso: Pork with modified fatty acid composition and berries, Pork, Pork and Finnish berriesPork with modified fatty acid composition | Dietary supplement | Modified pork |
| PorkPork with normal fat composition | Dietary supplement | Normal pork |
| Pork and berriesPork with normal fat composition and Finnish berries | Dietary supplement | Normal pork and berries |
Primary outcome
Change in plasma fatty acids as a measure of dietary fatty acid modification
Time frame: 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)
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.
5 secondary outcomes
Changes in plasma lipids as a measure of dietary modification
Time frame: 4 weeks
Concentration of polyphenolics in fecal water as a measure of consumption of berries
Time frame: 4 weeks
Change in hemoglobin as a measure of dietary modification
Time frame: 4 weeks
Change in blood pressure as a measure of dietary modofcation
Time frame: 4 weeks
Weight development during the study period
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 40120775Onali T, Slaba H, Jian C, Koivumaki T, Paivarinta E, Marttinen M, Maattanen M, Salonen A, Pajari AM. Berry supplementation in healthy volunteers modulates gut microbiota, increases fecal polyphenol metabolites and reduces viability of colon cancer cells exposed to fecal water- a randomized controlled trial. J Nutr Biochem. 2025 Jul;141:109906. doi: 10.1016/j.jnutbio.2025.109906. Epub 2025 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Maria Pajari, PhD principal investigator
Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki
Marja Mutanen, PhD principal investigator
Division of Nutrition, Department of Food and Environmental Sciences, University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified pork, Pork and Pork and berries in people with Cardiovascular Diseases, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma fatty acids as a measure of dietary fatty acid modification (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02469285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.