Fat Quality and Postprandial Inflammation (PI:fat)
Primary Purpose
Inflammatory Response, Inflammation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fat intake
Sponsored by
About this trial
This is an interventional prevention trial for Inflammatory Response focused on measuring inflammation, diet, fat
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Butter
Coconut
Corn oil
Flax seed oil
Arm Description
Butter based meal
Coconut based meal
Corn oil based meal
Flax seed oil based meal
Outcomes
Primary Outcome Measures
Inflammation markers
Cytokines, chemokines, endothelial factors
Secondary Outcome Measures
Lipoproteins
Triglycerides, VLDL
Lipidomics
Lipidomics characterization of lipid classes
Blood glucose
Capillary glucose sampling
Blood pressure
Systolic and diastolic
Gene expression
Gene expression in peripheral blood mononuclear cells in a subset (N=10) participants
Energy expenditure
Metabolic chamber by indirect calorimetry in a subset (N=5) participants
Full Information
NCT ID
NCT05674708
First Posted
January 3, 2023
Last Updated
January 10, 2023
Sponsor
Göteborg University
Collaborators
University of Oslo, Chalmers University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT05674708
Brief Title
Fat Quality and Postprandial Inflammation
Acronym
PI:fat
Official Title
Impact of Fat Quality on Postprandial Inflammation (PI:Fat): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
University of Oslo, Chalmers University of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Response, Inflammation
Keywords
inflammation, diet, fat
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Butter
Arm Type
Active Comparator
Arm Description
Butter based meal
Arm Title
Coconut
Arm Type
Active Comparator
Arm Description
Coconut based meal
Arm Title
Corn oil
Arm Type
Active Comparator
Arm Description
Corn oil based meal
Arm Title
Flax seed oil
Arm Type
Active Comparator
Arm Description
Flax seed oil based meal
Intervention Type
Other
Intervention Name(s)
Fat intake
Intervention Description
Four different sources of dietary fat
Primary Outcome Measure Information:
Title
Inflammation markers
Description
Cytokines, chemokines, endothelial factors
Time Frame
0 and 6 hours
Secondary Outcome Measure Information:
Title
Lipoproteins
Description
Triglycerides, VLDL
Time Frame
0, 2, 4 and 6 hours
Title
Lipidomics
Description
Lipidomics characterization of lipid classes
Time Frame
0, 2, 4 and 6 hours
Title
Blood glucose
Description
Capillary glucose sampling
Time Frame
0, 0.5, 1, 2, 4, 6 hours
Title
Blood pressure
Description
Systolic and diastolic
Time Frame
0, 0.5, 1, 2, 4, 6 hours
Title
Gene expression
Description
Gene expression in peripheral blood mononuclear cells in a subset (N=10) participants
Time Frame
0 and 4 hours
Title
Energy expenditure
Description
Metabolic chamber by indirect calorimetry in a subset (N=5) participants
Time Frame
0-6 hours, continous measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linnea Bärebring, PhD
Phone
+46317863771
Email
linnea.barebring@gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linnea Bärebring, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Fat Quality and Postprandial Inflammation
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