Pizza Meal Challenge and Immunometabolism (PIMETA)

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Pizza meal challenge

• Registration Number: NCT04175249
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2019-11-26
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pizza meal challenge	Pizza meal challenge	Vegetarian pizza containing 10 grams of salt

Primary Outcome Measures

Name	Time	Method
Oxygen consumption rate of immune cells	3 hours after the pizza compared to baseline	OCR (pmol oxygen/min/1000 cells) measured by Seahorse

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Experimental & Clinical Research Center; 🇩🇪 Berlin, Germany