Fat Quality and Postprandial Inflammation (PI:fat)

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:

1. What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?
2. Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?
3. 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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Inflammatory Response
• Intervention / Treatment: Other: Fat intake

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:

1. butter
2. coconut oil
3. corn oil
4. 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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden
    • University of Gothenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI >18.5
• Willingness to eat study meals

Exclusion Criteria:

• Diabetes
• Cardiovascular disease
• Cancer
• Dyslipidemia
• Anemia (Hb <100)
• Habitual intake of anti-inflammatory drugs
• Recent weight change (>±5%)
• Pregnancy, lactation
• Current smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Butter; Butter based meal	Other: Fat intake; Four different sources of dietary fat
Active Comparator: Coconut; Coconut based meal	Other: Fat intake; Four different sources of dietary fat
Active Comparator: Corn oil; Corn oil based meal	Other: Fat intake; Four different sources of dietary fat
Active Comparator: Flax seed oil; Flax seed oil based meal	Other: Fat intake; Four different sources of dietary fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation markers	Cytokines, chemokines, endothelial factors	0, 2, 4 and 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipoproteins	Triglycerides, VLDL	0, 2, 4 and 6 hours
Lipidomics	Lipidomics characterization of lipid classes	0, 2, 4 and 6 hours
Blood glucose	Capillary glucose sampling	0, 0.5, 1, 2, 4, 6 hours
Blood pressure	Systolic and diastolic	0, 0.5, 1, 2, 4, 6 hours
Gene expression	Gene expression in peripheral blood mononuclear cells in a subset (N=10) participants	0 and 4 hours

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: University of Oslo; Chalmers University of Technology
• Investigators: Principal Investigator: Linnea Bärebring, PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: inflammation; diet; fat
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2022-05898-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No