HealthyPIMETANCT04175249
Pizza Meal Challenge and Immunometabolism (PIMETA)
A study testing Pizza meal challenge in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pizza meal challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 26 Nov 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
Who cannot join
- Severe, manifest illnesses in need of treatment
- Pathological lab results
- Inability to understand significance and scope of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Pizza meal challenge
- Keywords
- Salt challenge, Immune cell metabolism, Oxygen consumption rate, Extracellular acidification rate, Cytokine production
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pizza meal challengeOther
Vegetarian pizza containing 10 grams of salt
| Study group | Role | What they receive |
|---|---|---|
| Pizza meal challenge | Experimental | Vegetarian pizza containing 10 grams of salt Receives: Other: Pizza meal challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption rate of immune cells
OCR (pmol oxygen/min/1000 cells) measured by Seahorse
Measured: 3 hours after the pizza compared to baseline
Secondary outcomes (7)
Oxygen consumption rate of immune cells
OCR (pmol oxygen/min/1000 cells) measured by Seahorse
Measured: 3 and 8 hours after the pizza adjusted for plasma sodium concentration compared to baseline
Plasma sodium
Plasma sodium concentration (mmol/l)
Measured: 3 and 8 hours after the pizza compared to baseline
Mitochondrial membrane potential of immune cells
Mitochondrial membrane potential (Mean Fluorescence Intensity of TMRE) measured by flow cytometry
Measured: 3 and 8 hours after the pizza compared to baseline
Extracellular acidification rate of immune cells
ECAR (mpH/min/1000 cells) measured by Seahorse
Measured: 3 and 8 hours after the pizza compared to baseline
Interleukin 17 release after monocyte and T cell co-culture
IL-17 concentration (pg/ml) measured by ELISA
Measured: 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
INF-g concentration (pg/ml) measured by ELISA
Measured: Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture
Adenosine triphophate production of immune cells
Percent change of luminescence (%) measured by Luminescence Assay
Measured: 3 and 8 hours after the pizza compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start26 Nov 2019
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Maehler, Charite University, Berlin, Germany
- Investigators
- Dominik N. Müller, PhD, Principal investigator, Charite University, Berlin, GermanyAnja Mähler, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175249
- Sponsor's protocol ID
- PIMETA
- Acronym
- PIMETA
- Status last verified
- Jul 2022
- First submitted
- 21 Nov 2019
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Publications
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.
PubMed 33906377
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pizza Meal Challenge on the Immunometabolism of Monocytes and T Cells
- ClinicalTrials.gov ID
- NCT04175249
- Acronym / sponsor ID
- PIMETA / PIMETA
- Conditions
- Healthy
- Keywords
- Salt challenge, Immune cell metabolism, Oxygen consumption rate, Extracellular acidification rate, Cytokine production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pizza meal challenge | Experimental | Other: Pizza meal challengeVegetarian pizza containing 10 grams of salt |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women
Key exclusion criteria (3 listed)
- Severe, manifest illnesses in need of treatment
- Pathological lab results
- Inability to understand significance and scope of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pizza meal challengeVegetarian pizza containing 10 grams of salt | Other | Pizza meal challenge |
Primary outcome
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
7 secondary outcomes
Oxygen consumption rate of immune cells
Time frame: 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
Mitochondrial membrane potential of immune cells
Time frame: 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
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
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
Adenosine triphophate production of immune cells
Time frame: 3 and 8 hours after the pizza compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Results publication: PubMed 33906377Geisberger 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik N. Müller, PhD principal investigator
Charite University, Berlin, Germany
Anja Mähler, PhD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pizza meal challenge in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption rate of immune cells (time frame: 3 hours after the pizza compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.