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NCT04175249 Clinical Trial

Pizza Meal Challenge and Immunometabolism (PIMETA)

Healthy Clinical Trial

— PIMETA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04175249
Other study ID # PIMETA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2019
Est. completion date May 30, 2020

Study information
Verified date July 2022
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Pizza meal challenge
Vegetarian pizza containing 10 grams of salt

Locations
Country Name City State
Germany Experimental & Clinical Research Center Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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, Jants — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Oxygen consumption rate of immune cells OCR (pmol oxygen/min/1000 cells) measured by Seahorse 3 hours after the pizza compared to baseline
Secondary Oxygen consumption rate of immune cells OCR (pmol oxygen/min/1000 cells) measured by Seahorse 3 and 8 hours after the pizza adjusted for plasma sodium concentration compared to baseline
Secondary Plasma sodium Plasma sodium concentration (mmol/l) 3 and 8 hours after the pizza compared to baseline
Secondary Mitochondrial membrane potential of immune cells Mitochondrial membrane potential (Mean Fluorescence Intensity of TMRE) measured by flow cytometry 3 and 8 hours after the pizza compared to baseline
Secondary Extracellular acidification rate of immune cells ECAR (mpH/min/1000 cells) measured by Seahorse 3 and 8 hours after the pizza compared to baseline
Secondary Interleukin 17 release after monocyte and T cell 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
Secondary Interferon-gamma release after monocyte and T cell 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
Secondary Adenosine triphophate production of immune cells Percent change of luminescence (%) measured by Luminescence Assay 3 and 8 hours after the pizza compared to baseline
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