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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

Tracking Information
First Submitted Date  ICMJE November 21, 2019
First Posted Date  ICMJE November 22, 2019
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE November 26, 2019
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
  • 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
  • Plasma sodium [ Time Frame: 3 and 8 hours after the pizza compared to baseline ]
    Plasma sodium concentration (mmol/l)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • 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
  • Plasma sodium [ Time Frame: 3 and 8 hours after the pizza compared to baseline ]
    Plasma sodium concentration (mmol/l)
  • 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
  • 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
  • Cytokine 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 ]
    Cytokine concentration (pg/ml) measured by ELISA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pizza Meal Challenge and Immunometabolism (PIMETA)
Official Title  ICMJE Effects of a Pizza Meal Challenge on the Immunometabolism of Monocytes and T Cells
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Other: Pizza meal challenge
Vegetarian pizza containing 10 grams of salt
Study Arms  ICMJE Experimental: Pizza meal challenge
Vegetarian pizza containing 10 grams of salt
Intervention: Other: Pizza meal challenge
Publications * Geisberger S, Bartolomaeus H, Neubert P, Willebrand R, Zasada C, Bartolomaeus T, McParland V, Swinnen D, Geuzens A, Maifeld A, Krampert L, Vogl M, Mähler A, Wilck N, Markó L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Müller DN. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021 Jul 13;144(2):144-158. doi: 10.1161/CIRCULATIONAHA.120.052788. Epub 2021 Apr 28. Erratum in: Circulation. 2021 Jul 13;144(2):e37.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 30, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04175249
Other Study ID Numbers  ICMJE PIMETA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Anja Maehler, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominik N. Müller, PhD Charite University, Berlin, Germany
Principal Investigator: Anja Mähler, PhD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP