Inflammatory ResponsePI:fatNCT05674708
Fat Quality and Postprandial Inflammation
A study testing Fat intake in people with Inflammatory Response and Inflammation, run by Göteborg University at 1 site in Sweden.
Trial summary
This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Inflammation
- What is being tested?
- Fat intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 7 Feb 2023to 23 Jan 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >18.5
- Willingness to eat study meals
Who cannot join
- Diabetes
- Cardiovascular disease
- Cancer
- Dyslipidemia
- Anemia (Hb <100)
- Habitual intake of anti-inflammatory drugs
Show all 9Show fewer
- Recent weight change (>±5%)
- Pregnancy, lactation
- Current smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fat Quality on Postprandial Inflammation (PI:Fat): a Randomized Controlled Trial
This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response.
The main questions it aims to answer are:
Read more
- What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?
- Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?
- Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline?
Participants will consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours.
Read the detailed description
A randomized crossover single meal study will be conducted, comparing four isocaloric meals. The study will be carried out at two sites; one study center is located in Gothenburg, Sweden (Department of Internal Medicine and Clinical Nutrition at the University of Gothenburg) and one study center in Oslo, Norway (Department of Nutrition, University of Oslo).
A total of 20 healthy adults will be recruited and consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours after. Each of the four meals will be separated by a 1 month washout. Subjects will be asked to abstain from rigorous physical activity, alcohol and high-fat foods the day prior to their test meal days.
Four isocaloric high-fat meals with different fatty acid profiles will be compared:
- butter
- coconut oil
- corn oil
- flax seed oil
At test meal days, study outcomes will be assessed at baseline (0h, fasting, pre meal), 30 min, 1h, 2h, 4h and at 6h (endpoint). At these timepoints, blood pressure will be measured and blood glucose sampled through capillary blood. At baseline, 2h, 4h and 6h, blood will be drawn by venipuncture. Urine will be collected when the participants need to void.
Blood will be collected and handled according to a standardized protocol to prevent any degradation, before stored in -80°C until analysis. At baseline and endpoint, peripheral blood mononuclear cells from blood samples will be isolated using cell preparation tubes and stored at -80 °C until RNA isolation. Lipids, lipoprotein profile and inflammation markers (e.g. cytokines, chemokines, endothelial factors) will be analyzed in samples from 0, 2, 4 and 6 hours.
Differences between meals in the outcomes will be compared using area under the curve and mixed models effect.
- Conditions
- Inflammatory Response, Inflammation
- Being tested
- Fat intake
- Keywords
- inflammation, diet, fat
- Medical subject headings
- Inflammation, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat intakeOther
Four different sources of dietary fat
| Study group | Role | What they receive |
|---|---|---|
| Butter | Active comparator | Butter based meal Receives: Other: Fat intake |
| Coconut | Active comparator | Coconut based meal Receives: Other: Fat intake |
| Corn oil | Active comparator | Corn oil based meal Receives: Other: Fat intake |
| Flax seed oil | Active comparator | Flax seed oil based meal Receives: Other: Fat intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation markers
Cytokines, chemokines, endothelial factors
Measured: 0, 2, 4 and 6 hours
Secondary outcomes (5)
Lipoproteins
Triglycerides, VLDL
Measured: 0, 2, 4 and 6 hours
Lipidomics
Lipidomics characterization of lipid classes
Measured: 0, 2, 4 and 6 hours
Blood glucose
Capillary glucose sampling
Measured: 0, 0.5, 1, 2, 4, 6 hours
Blood pressure
Systolic and diastolic
Measured: 0, 0.5, 1, 2, 4, 6 hours
Gene expression
Gene expression in peripheral blood mononuclear cells in a subset (N=10) participants
Measured: 0 and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start7 Feb 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
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 Inflammatory ResponseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Chalmers University of Technology
- Responsible party
- Sponsor
- Investigators
- Linnea Bärebring, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674708
- Sponsor's protocol ID
- 2022-05898-01
- Acronym
- PI:fat
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limani N, Henriksen HB, Minge MM, Sandoval V, Landberg R, Lindqvist HM, Holven KB, Ulven SM, Barebring L. Effect of different sources of saturated and polyunsaturated fatty acids on postprandial inflammation: A double-blind randomized crossover trial. Clin Nutr ESPEN. 2026 Aug;74:103335. doi: 10.1016/j.clnesp.2026.103335. Epub 2026 May 12.
PubMed 42128091
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fat Quality on Postprandial Inflammation (PI:Fat): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05674708
- Acronym / sponsor ID
- PI:fat / 2022-05898-01
- Conditions
- Inflammatory Response, Inflammation
- Keywords
- inflammation, diet, fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, Chalmers University of Technology
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 6 Jan 2023 (actual)
- 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.
This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response.
The main questions it aims to answer are:
- What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?
- Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?
- Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline?
Participants will consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours.
Detailed description
A randomized crossover single meal study will be conducted, comparing four isocaloric meals. The study will be carried out at two sites; one study center is located in Gothenburg, Sweden (Department of Internal Medicine and Clinical Nutrition at the University of Gothenburg) and one study center in Oslo, Norway (Department of Nutrition, University of Oslo).
A total of 20 healthy adults will be recruited and consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours after. Each of the four meals will be separated by a 1 month washout. Subjects will be asked to abstain from rigorous physical activity, alcohol and high-fat foods the day prior to their test meal days.
Four isocaloric high-fat meals with different fatty acid profiles will be compared:
- butter
- coconut oil
- corn oil
- flax seed oil
At test meal days, study outcomes will be assessed at baseline (0h, fasting, pre meal), 30 min, 1h, 2h, 4h and at 6h (endpoint). At these timepoints, blood pressure will be measured and blood glucose sampled through capillary blood. At baseline, 2h, 4h and 6h, blood will be drawn by venipuncture. Urine will be collected when the participants need to void.
Blood will be collected and handled according to a standardized protocol to prevent any degradation, before stored in -80°C until analysis. At baseline and endpoint, peripheral blood mononuclear cells from blood samples will be isolated using cell preparation tubes and stored at -80 °C until RNA isolation. Lipids, lipoprotein profile and inflammation markers (e.g. cytokines, chemokines, endothelial factors) will be analyzed in samples from 0, 2, 4 and 6 hours.
Differences between meals in the outcomes will be compared using area under the curve and mixed models effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Butter | Active comparator | Other: Fat intakeButter based meal |
| Coconut | Active comparator | Other: Fat intakeCoconut based meal |
| Corn oil | Active comparator | Other: Fat intakeCorn oil based meal |
| Flax seed oil | Active comparator | Other: Fat intakeFlax seed oil based meal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI >18.5
- Willingness to eat study meals
Key exclusion criteria (9 listed)
- Diabetes
- Cardiovascular disease
- Cancer
- Dyslipidemia
- Anemia (Hb <100)
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 |
|---|---|---|
| Fat intakeFour different sources of dietary fat | Other | Butter, Coconut, Corn oil, Flax seed oil |
Primary outcome
Inflammation markers
Time frame: 0, 2, 4 and 6 hours
Cytokines, chemokines, endothelial factors
5 secondary outcomes
Lipoproteins
Time frame: 0, 2, 4 and 6 hours
Lipidomics
Time frame: 0, 2, 4 and 6 hours
Blood glucose
Time frame: 0, 0.5, 1, 2, 4, 6 hours
Blood pressure
Time frame: 0, 0.5, 1, 2, 4, 6 hours
Gene expression
Time frame: 0 and 4 hours
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 28 Feb 2024.
- Derived from this study: PubMed 42128091Limani N, Henriksen HB, Minge MM, Sandoval V, Landberg R, Lindqvist HM, Holven KB, Ulven SM, Barebring L. Effect of different sources of saturated and polyunsaturated fatty acids on postprandial inflammation: A double-blind randomized crossover trial. Clin Nutr ESPEN. 2026 Aug;74:103335. doi: 10.1016/j.clnesp.2026.103335. Epub 2026 May 12.
- Individual participant dataSharing planned: No
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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.
Linnea Bärebring, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat intake in people with Inflammatory Response and Inflammation, run by Göteborg University at 1 site in Sweden.
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 2 inclusion and 9 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 28 Feb 2024. 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 Sweden. 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?
Inflammation markers (time frame: 0, 2, 4 and 6 hours). 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 NCT05674708, 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 28 Feb 2024.