Pizza Meal Challenge and Immunometabolism (PIMETA)

NCT04175249 | Completed

• 1 other identifier: PIMETA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Salt challenge; Immune cell metabolism; Oxygen consumption rate; Extracellular acidification rate; Cytokine production

Outcome Measures

Primary Outcomes (1)

• Oxygen consumption rate of immune cells

  OCR (pmol oxygen/min/1000 cells) measured by Seahorse

  3 hours after the pizza compared to baseline

Secondary Outcomes (7)

• Oxygen consumption rate of immune cells

  3 and 8 hours after the pizza adjusted for plasma sodium concentration compared to baseline

• Plasma sodium

  3 and 8 hours after the pizza compared to baseline

• Mitochondrial membrane potential of immune cells

  3 and 8 hours after the pizza compared to baseline

• Extracellular acidification rate of immune cells

  3 and 8 hours after the pizza compared to baseline

• 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

Study Arms (1)

Pizza meal challenge

EXPERIMENTAL

Vegetarian pizza containing 10 grams of salt

Other: Pizza meal challenge

Interventions

Pizza meal challenge OTHER

Vegetarian pizza containing 10 grams of salt

Pizza meal challenge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy men and women

You may not qualify if:

• Severe, manifest illnesses in need of treatment
• Pathological lab results
• Inability to understand significance and scope of the study

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

Related 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, Mahler A, Wilck N, Marko L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Muller 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.

  PMID: 33906377 RESULT

Study Officials

• Dominik N. Müller, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Anja Mähler, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: November 26, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DE (1)