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Pizza Meal Challenge and Immunometabolism (PIMETA) (PIMETA)

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ClinicalTrials.gov Identifier: NCT04175249
Recruitment Status : Completed
First Posted : November 22, 2019
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Anja Maehler, Charite University, Berlin, Germany

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Pizza meal challenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of a Pizza Meal Challenge on the Immunometabolism of Monocytes and T Cells
Actual Study Start Date : November 26, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: Pizza meal challenge
Vegetarian pizza containing 10 grams of salt
Other: Pizza meal challenge
Vegetarian pizza containing 10 grams of salt




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175249


Locations
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Germany
Experimental & Clinical Research Center
Berlin, Germany, 13125
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Dominik N. Müller, PhD Charite University, Berlin, Germany
Principal Investigator: Anja Mähler, PhD Charite University, Berlin, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anja Maehler, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04175249    
Other Study ID Numbers: PIMETA
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anja Maehler, Charite University, Berlin, Germany:
Salt challenge
Immune cell metabolism
Oxygen consumption rate
Extracellular acidification rate
Cytokine production