PI:fat: Fat Quality and Postprandial Inflammation

Sponsor
Göteborg University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05674708
Collaborator
University of Oslo (Other), Chalmers University of Technology (Other)
40
4
24

Study Details

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:
  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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fat intake
N/A

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:
  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. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Impact of Fat Quality on Postprandial Inflammation (PI:Fat): a Randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Inflammation markers [0 and 6 hours]

    Cytokines, chemokines, endothelial factors

Secondary Outcome Measures

  1. Lipoproteins [0, 2, 4 and 6 hours]

    Triglycerides, VLDL

  2. Lipidomics [0, 2, 4 and 6 hours]

    Lipidomics characterization of lipid classes

  3. Blood glucose [0, 0.5, 1, 2, 4, 6 hours]

    Capillary glucose sampling

  4. Blood pressure [0, 0.5, 1, 2, 4, 6 hours]

    Systolic and diastolic

  5. Gene expression [0 and 4 hours]

    Gene expression in peripheral blood mononuclear cells in a subset (N=10) participants

  6. Energy expenditure [0-6 hours, continous measurement]

    Metabolic chamber by indirect calorimetry in a subset (N=5) participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Göteborg University
  • University of Oslo
  • Chalmers University of Technology

Investigators

  • Principal Investigator: Linnea Bärebring, PhD, Göteborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT05674708
Other Study ID Numbers:
  • 2022-05898-01
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Göteborg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023