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NCT Number: NCT06198374

Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults ( Pro-Health)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium propionate

Dietary Supplement

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.

Other names: Propicum

Placebo

Other

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.

Primary outcomes

  1. Change in count of regulatory T-cells from baseline to week 4

    Time frame: Baseline visit (week 0) in comparison to week 4

    Analysis of Treg counts in whole blood (absolute quantification) and peripheral blood

Secondary outcomes

  1. Propionic acid serum levels and targeted metabolomics

    Time frame: Baseline visit (week 0); Week 2; Week 4

    Analysis of PA serum levels and other microbially-derived metabolites by GC-MS and LC-MS

  2. Relative abundance of different immune cell subsets with Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)

    Time frame: Baseline visit (week 0); Week 2; Week 4

    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).

  3. 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

    Time frame: Baseline visit (week 0); Week 4

    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.

  4. Single cell RNA sequencing of immune cells

    Time frame: Baseline visit (week 0); Week 4

    Analysis of the transcriptome of immune cells using cellular indexing of transcriptomes and epitopes (CITEseq)

  5. Measuring the intestinal barrier function by measuring the concentration of different leaky gut markers

    Time frame: Baseline visit (week 0); Week 2; Week 4

    Analysis of biomarkers for intestinal barrier function, such as sCD14, zonulin-1 and LPS

  6. Taxonomy of the fecal microbiome

    Time frame: Baseline visit (week 0); Week 4

    The taxonomy of the fecal microbiome will be anayzed using 16S RNA amplicon sequencing.

  7. Cardiovascular Phenothyping

    Time frame: Baseline visit (week 0); Week 2; Week 4

    Analysis of heart rate over time.

  8. Cardiovascular Phenotyping

    Time frame: Baseline visit (week 0); Week 2; Week 4

    Analysis of blood pressure over time.

  9. Cholesterol levels

    Time frame: Baseline visit (week 0); Week 2; Week 4

    Cholestrol levels will be assessed using standard clinical lab values

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults.

Acronym: Pro-Health

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 10, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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