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Completed

NCT Number: NCT05674708

Fat Quality and Postprandial Inflammation

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gothenburg

Gothenburg, Sweden

About this study

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:

  • 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fat intake

Other

Four different sources of dietary fat

Primary outcomes

  1. Inflammation markers

    Time frame: 0, 2, 4 and 6 hours

    Cytokines, chemokines, endothelial factors

Secondary outcomes

  1. Lipoproteins

    Time frame: 0, 2, 4 and 6 hours

    Triglycerides, VLDL

  2. Lipidomics

    Time frame: 0, 2, 4 and 6 hours

    Lipidomics characterization of lipid classes

  3. Blood glucose

    Time frame: 0, 0.5, 1, 2, 4, 6 hours

    Capillary glucose sampling

  4. Blood pressure

    Time frame: 0, 0.5, 1, 2, 4, 6 hours

    Systolic and diastolic

  5. Gene expression

    Time frame: 0 and 4 hours

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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Chalmers University of Technology
  • University of Oslo

Registry information

Official study title

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

Acronym: PI:fat

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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