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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
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Response focused on measuring inflammation, diet, fat

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 3, 2023
    Last Updated
    January 10, 2023
    Sponsor
    Göteborg University
    Collaborators
    University of Oslo, Chalmers University of Technology
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    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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