Pizza Meal Challenge and Immunometabolism (PIMETA) (PIMETA)

July 7, 2022 updated by: Anja Maehler, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 13125
        • Experimental & Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pizza meal challenge
Vegetarian pizza containing 10 grams of salt
Vegetarian pizza containing 10 grams of salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 hours after the pizza compared to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 and 8 hours after the pizza adjusted for plasma sodium concentration compared to baseline
Plasma sodium
Time Frame: 3 and 8 hours after the pizza compared to baseline
Plasma sodium concentration (mmol/l)
3 and 8 hours after the pizza compared to baseline
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
3 and 8 hours after the pizza compared to baseline
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
3 and 8 hours after the pizza compared to baseline
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
Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture
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
Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture
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
3 and 8 hours after the pizza compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dominik N. Müller, PhD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2019

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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