Clinical trial NCT06198374: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment randomized, double-blind, placebo-controlled
Primary purpose: BASIC_SCIENCE

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 criteria: 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

Primary outcomes:
measure: Change in count of regulatory T-cells from baseline to week 4
timeFrame: Baseline visit (week 0) in comparison to week 4
Secondary outcomes:
measure: Propionic acid serum levels and targeted metabolomics
timeFrame: Baseline visit (week 0); Week 2; Week 4
measure: Relative abundance of different immune cell subsets with Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)
timeFrame: Baseline visit (week 0); Week 2; Week 4
measure: 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
timeFrame: Baseline visit (week 0); Week 4
measure: Single cell RNA sequencing of immune cells
timeFrame: Baseline visit (week 0); Week 4
measure: Measuring the intestinal barrier function by measuring the concentration of different leaky gut markers
timeFrame: Baseline visit (week 0); Week 2; Week 4
measure: Taxonomy of the fecal microbiome
timeFrame: Baseline visit (week 0); Week 4
measure: Cardiovascular Phenothyping
timeFrame: Baseline visit (week 0); Week 2; Week 4
measure: Cardiovascular Phenotyping
timeFrame: Baseline visit (week 0); Week 2; Week 4
measure: Cholesterol levels
timeFrame: Baseline visit (week 0); Week 2; Week 4
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
Study officials:
References: