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

NCT ID: NCT06198374

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-05-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sodium propionate

Intervention Type: 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 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Sodium propionate

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: OTHER

Other Intervention Names

Propicum

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Johannes Benjamin Holle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Berlin, , Germany

Countries

Germany

Other Identifiers

EA2/195/22_2

Identifier Type: -

Identifier Source: org_study_id