- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175249
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
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
Keywords
Other Study ID Numbers
- PIMETA
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Pizza meal challenge
-
Virginia Commonwealth UniversityCompleted
-
Aarhus University HospitalDiabetesforeningenUnknown
-
North Dakota State UniversityCompleted
-
Emory UniversityCenters for Disease Control and PreventionCompleted
-
King's College LondonCompleted
-
Federico II UniversityCompletedSatiety Response | Sodium Retention | Carbohydrate MetabolismItaly
-
USDA, Western Human Nutrition Research CenterRecruiting
-
Menzies Institute for Medical ResearchDeakin UniversityActive, not recruiting
-
Emory UniversityTerminated
-
Wageningen University and ResearchCompletedGlucose Metabolism | Lipid MetabolismNetherlands