Evaluating a dietary formulation with MCTs and fiber for patients with psoriatic arthritis

Trial Clinico Randomizzato e Doppio-cieco Sull'Efficacia di Una Formulazione Alimentare Contenente Trigliceridi a Media Catena (MCT) e Fibre in Pazienti Con Artrite Psoriasica

This study is testing if a special diet with MCTs and fiber can help improve the quality of life for people with psoriatic arthritis who are already on medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Dr. Schär AG / SPA (industry)
• Locations: 1 site (Milano)
• Trial ID: NCT06990152 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy of a dietary formulation containing medium-chain triglycerides (MCTs) and vegetable fibers in improving the quality of life for patients with psoriatic arthritis (PsA). Over a period of three months, participants will be monitored for changes in health-related quality of life, disease activity, and various metabolic and inflammatory blood parameters. The study focuses on patients who are already on stable pharmacological treatment and have low disease activity, exploring the potential benefits of dietary interventions alongside traditional therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with a clinical diagnosis of psoriatic arthritis, low disease activity, and stable pharmacological treatment.

Not a fit: Patients with high disease activity, metabolic diseases, or those on specific diets like vegan or ketogenic may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with psoriatic arthritis a novel dietary approach to enhance their quality of life and manage their condition more effectively.

How similar studies have performed: While dietary interventions in chronic conditions are being explored, this specific approach using MCTs and fiber in psoriatic arthritis is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Adult patients: aged 18-80 years;
* Clinical diagnosis of PsA meeting the CASPAR classification criteria;
* Low disease activity (4 \< DAPSA ≤ 14) at the time of recruitment;
* Under stable pharmacological treatment with disease-modifying antirheumatic drugs (DMARDs) (conventional synthetic, targeted synthetic, or biological);
* Disease duration \> 6 months;
* Absence of metabolic diseases.

Exclusion Criteria:

* BMI ≥ 27 kg/m²;
* Current or desired pregnancies (confirmed by pregnancy test);
* Disease activity in remission (DAPSA ≤ 4), moderate (14 \< DAPSA ≤ 28), or high (DAPSA \> 28) at the time of recruitment;
* Pediatric onset of the disease (\< 16 years);
* Patients on a vegan, ketogenic, or MCT-rich diet (containing MCT in supplement form or high amounts of palm or coconut oil);
* Presence of ketoacidosis/metabolic acidosis, decompensated liver cirrhosis, or medium-chain acyl-CoA dehydrogenase (MCAD) deficiency;
* Type 2 diabetes, cardiovascular diseases, hypertension, ischemic diseases, renal failure, malignant tumors, respiratory diseases, dyslipidemia, fibromyalgia, metabolic syndrome;
* Major depression;
* Gastritis, esophagitis, reflux syndrome, chronic inflammatory bowel diseases (IBD);
* Lactose intolerance.

Where this trial is running

Milano

• ASST Gaetano Pini CTO, UOC Clinica Reumatologica — Milano, Italy (RECRUITING)

Study contacts

• Principal investigator: Francesca Ingegnoli, Professor — ASST Gaetano Pini CTO, UOC Clinica Reumatologica
• Study coordinator: Giulia Gaudioso, Medical Affairs Manager, PhD

Conditions: Psoriatic Arthritis, medium-chain triglycerides, dietary fiber, psoriatic arthritis, CALIPSO