Fat Quality and Postprandial Inflammation

Study Overview
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Brief Summary
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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
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A randomized crossover single meal study will be conducted, comparing four isocaloric meals. The study will be caried 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 30-40 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. Inflammation markers (e.g. cytokines, chemokines, endothelial factors, c-reactive protein) and inflammation-mediators (e.g. lipopolysaccharides, oxylipins) will be analyzed from 0h and 6h samples. Lipid and lipoprotein profile 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.

Official Title
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Impact of Fat Quality on Postprandial Inflammation (PI:Fat): a Randomized Controlled Trial

Conditions
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Inflammatory Response, Inflammation

Intervention / Treatment
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* Other: Fat intake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Butter<br>Butter based meal | Other: Fat intake<br>* Four different sources of dietary fat<br>|
| Active Comparator: Coconut<br>Coconut based meal | Other: Fat intake<br>* Four different sources of dietary fat<br>|
| Active Comparator: Corn oil<br>Corn oil based meal | Other: Fat intake<br>* Four different sources of dietary fat<br>|
| Active Comparator: Flax seed oil<br>Flax seed oil based meal | Other: Fat intake<br>* Four different sources of dietary fat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation markers | Cytokines, chemokines, endothelial factors | 0 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 | 
| Energy expenditure | Metabolic chamber by indirect calorimetry in a subset (N=5) participants | 0-6 hours, continous measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, diet, fat