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EA2/195/22_2

Impact of propionic acid on regulatory t cell function in healthy adults ( pro-health)
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06198374
Recrutement fermé
Dernière modification : 2025/02/16
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • PA Intervention.
    État du recrutement
    unknown
    Placebo Intervention
    État du recrutement
    unknown
    Données à jour depuis : 16 février 2025

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    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.

    Source : Importé depuis le centre

    Sites

    Centres participants

      1 centres
    • DEPARTMENT OF PEDIATRIC GASTROENTEROLOGY, NEPHROLOGY AND METABOLIC DISEASES, CHARITÉ-UNIVERSITÄTSMEDIZIN BERLIN

      Berlin

      GERMANY

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 16 février 2025
    Données à jour depuis : 19 fév.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06198374