Einfluss von Propionsäure auf die regulatorische T-Zellfunktion bei gesunden Erwachsenen (Pro-Health) (Pro-Health)
Einfluss von Propionsäure auf die regulatorische T-Zellfunktion bei gesunden Erwachsenen.
Pro-Health is a single-center, double-blind, randomized and placebo-controlled intervention study in healthy adults. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in healhty adults.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Chronic inflammation is a major risk factor of cardiovascular disease progression in CKD, irrespective of confounding comorbidities. Based on current knowledge, microbially-derived metabolites such as short chain fatty acids (SCFA) play an important role in the regulation of chronic inflammatory processes in CKD patients. Patients with CKD are known to have reduced serum levels of the SCFA propionic acid (PA), as a consequence of both gut microbial dysbiosis and reduced fiber intake. In animal and human studies the impact of PA on function and abundance of regulatory T cells (Treg) has been demonstrated. Consequently, the investigators aim to increase the PA serum levels by oral PA food supplementation in healthy adults in order to perspectively intervene with the same strategy in patients with CKD in the near future, with the target to increase abundance and function of antiinflammatory cells.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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State of Berlin
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Berlin, State of Berlin, Deutschland, 13353
- Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 18 - 40 years old
- Body weight: > 30kg
Exclusion Criteria:
- Disease or dysfunctions, which disqualifies the patient
- Incapacity of contract or any other circumstances, which prohibit the patient from understanding setup, meaning and entity of the study
- Acute infections
- Immunosuppressive therapy within the last 12 weeks before the start of the study
- Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study
- Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study
- Malignant diseases
- Pregnancy
- chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease
- alcohol- or drug abuse
- parallel participation on other interventional trials
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Placebo-Komparator: Placebo Intervention
The control-group receives a placebo instead of propionate. The placebo contains maltodextrin and the same amount of sodium chloride as compared to the PA intervention. The placebo is taken twice per day for 28 days. |
The patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function. |
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Experimental: PA Intervention.
The group which receives the PA as a dietary food supplement. A single capsule contains 500mg of sodiumpropionate, which is taken twice daily for 28 days. |
The patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in count of regulatory T-cells from baseline to week 4
Zeitfenster: Baseline visit (week 0) in comparison to week 4
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Analysis of Treg counts in whole blood (absolute quantification) and peripheral blood |
Baseline visit (week 0) in comparison to week 4
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Single cell RNA sequencing of immune cells
Zeitfenster: Baseline visit (week 0); Week 4
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Analysis of the transcriptome of immune cells using cellular indexing of transcriptomes and epitopes (CITEseq) |
Baseline visit (week 0); Week 4
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Taxonomy of the fecal microbiome
Zeitfenster: Baseline visit (week 0); Week 4
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The taxonomy of the fecal microbiome will be anayzed using 16S RNA amplicon sequencing. |
Baseline visit (week 0); Week 4
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Propionic acid serum levels and targeted metabolomics
Zeitfenster: Baseline visit (week 0); Week 2; Week 4
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Analysis of PA serum levels and other microbially-derived metabolites by GC-MS and LC-MS |
Baseline visit (week 0); Week 2; Week 4
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Relative abundance of different immune cell subsets with Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)
Zeitfenster: Baseline visit (week 0); Week 2; Week 4
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Patients PBMC will be thawed and immune cells we be analyzed using multicolor flow cytometry and mass cytometry. By using a broad range of different antibodies combined in several panels the investigators will analyse distinct T cell subtypes including markers of activation, but also other immune cells (including B cells, dendritic cells, monocytes, natural killer cells). Data will reported in relation to parent populations (e.g. T heller cells in % of T cells). |
Baseline visit (week 0); Week 2; Week 4
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Measuring the suppressive function of regulatory T cells (Tregs) as percentage of proliferated conventional CD4-positive T cells with an in vitro T regulatory cell (Treg) suppression assay
Zeitfenster: Baseline visit (week 0); Week 4
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The suppressive capacity of patients Treg will be analyzed by co-cultivation with conventional, stimulated T cells (Tconv) in different proportions (Treg:Tconv). The proliferation of Tconv will be reported. |
Baseline visit (week 0); Week 4
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Measuring the intestinal barrier function by measuring the concentration of different leaky gut markers
Zeitfenster: Baseline visit (week 0); Week 2; Week 4
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Analysis of biomarkers for intestinal barrier function, such as sCD14, zonulin-1 and LPS |
Baseline visit (week 0); Week 2; Week 4
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Cardiovascular Phenothyping
Zeitfenster: Baseline visit (week 0); Week 2; Week 4
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Analysis of heart rate over time. |
Baseline visit (week 0); Week 2; Week 4
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Cardiovascular Phenotyping
Zeitfenster: Baseline visit (week 0); Week 2; Week 4
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Analysis of blood pressure over time. |
Baseline visit (week 0); Week 2; Week 4
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Cholesterol levels
Zeitfenster: Baseline visit (week 0); Week 2; Week 4
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Cholestrol levels will be assessed using standard clinical lab values |
Baseline visit (week 0); Week 2; Week 4
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EA2/195/22 (2)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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