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

NCT06198374 | Active Not Recruiting

• 1 other identifier: EA2/195/22_2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline visit (week 0) in comparison to week 4

Secondary Outcomes (9)

• Propionic acid serum levels and targeted metabolomics

  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)

  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

  Baseline visit (week 0); Week 4

• Single cell RNA sequencing of immune cells

  Baseline visit (week 0); Week 4

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

  Baseline visit (week 0); Week 2; Week 4

Study Arms (2)

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.

Dietary Supplement: Sodium propionate

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.

Other: Placebo

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.

Also known as: Propicum

PA Intervention.

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.

Placebo Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Body weight: \> 30kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

sodium propionate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 8, 2024
• Primary Completion: February 28, 2024
• Study Completion: May 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

DE (1)