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Completed

NCT Number: NCT04175249

Pizza Meal Challenge and Immunometabolism (PIMETA)

High salt intake is a major risk factor for cardiovascular events, including stroke, heart disease and kidney failure. Pizza is a popular salty food. In this exploratory pilot study, the effects of a pizza meal challenge on immunometabolism in healthy subjects will be tested.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Experimental & Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women

Exclusion criteria

  • Severe, manifest illnesses in need of treatment
  • Pathological lab results
  • Inability to understand significance and scope of the study

Treatment and study plan

Pizza meal challenge

Other

Vegetarian pizza containing 10 grams of salt

Primary outcomes

  1. Oxygen consumption rate of immune cells

    Time frame: 3 hours after the pizza compared to baseline

    OCR (pmol oxygen/min/1000 cells) measured by Seahorse

Secondary outcomes

  1. Oxygen consumption rate of immune cells

    Time frame: 3 and 8 hours after the pizza adjusted for plasma sodium concentration compared to baseline

    OCR (pmol oxygen/min/1000 cells) measured by Seahorse

  2. Plasma sodium

    Time frame: 3 and 8 hours after the pizza compared to baseline

    Plasma sodium concentration (mmol/l)

  3. Mitochondrial membrane potential of immune cells

    Time frame: 3 and 8 hours after the pizza compared to baseline

    Mitochondrial membrane potential (Mean Fluorescence Intensity of TMRE) measured by flow cytometry

  4. Extracellular acidification rate of immune cells

    Time frame: 3 and 8 hours after the pizza compared to baseline

    ECAR (mpH/min/1000 cells) measured by Seahorse

  5. Interleukin 17 release after monocyte and T cell co-culture

    Time frame: Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture

    IL-17 concentration (pg/ml) measured by ELISA

  6. Interferon-gamma release after monocyte and T cell co-culture

    Time frame: Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture

    INF-g concentration (pg/ml) measured by ELISA

  7. Adenosine triphophate production of immune cells

    Time frame: 3 and 8 hours after the pizza compared to baseline

    Percent change of luminescence (%) measured by Luminescence Assay

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Effects of a Pizza Meal Challenge on the Immunometabolism of Monocytes and T Cells

Acronym: PIMETA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 22, 2019
Registry last updated
Jul 11, 2022

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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