---
title: Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults ( Pro-Health)
nct_id: NCT06198374
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Charite University, Berlin, Germany
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06198374.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06198374"
ct_last_update_post_date: 2025-02-17
last_seen_at: "2026-05-12T06:52:30.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults ( Pro-Health)

**Official Title:** Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults.

**NCT ID:** [NCT06198374](https://clinicaltrials.gov/study/NCT06198374)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Charite University, Berlin, Germany
- **Conditions:** Healthy
- **Start Date:** 2024-01-08
- **Completion Date:** 2025-05-30
- **CT.gov Last Update:** 2025-02-17

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **PA Intervention.** (EXPERIMENTAL) — 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.
- **Placebo Intervention** (PLACEBO_COMPARATOR) — 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.

## Interventions

- **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.
- **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

- **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

- **Propionic acid serum levels and targeted metabolomics** _(time frame: Baseline visit (week 0); Week 2; Week 4)_
- **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)_
- **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)_
- **Single cell RNA sequencing of immune cells** _(time frame: Baseline visit (week 0); Week 4)_
- **Measuring the intestinal barrier function by measuring the concentration of different leaky gut markers** _(time frame: Baseline visit (week 0); Week 2; Week 4)_
- **Taxonomy of the fecal microbiome** _(time frame: Baseline visit (week 0); Week 4)_
- **Cardiovascular Phenothyping** _(time frame: Baseline visit (week 0); Week 2; Week 4)_
- **Cardiovascular Phenotyping** _(time frame: Baseline visit (week 0); Week 2; Week 4)_
- **Cholesterol levels** _(time frame: Baseline visit (week 0); Week 2; Week 4)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of pediatric gastroenterology, nephrology and metabolic diseases, charité-universitätsmedizin berlin|berlin||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06198374.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06198374*  
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