RECRUITINGINTERVENTIONAL

A Randomized, Double-blind Clinical Trial on the Efficacy of a Dietary Formulation Containing Medium-chain Triglycerides (MCT) and Fiber in 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

About This Trial

The primary objective of this study is to evaluate the effects of a formulation containing medium-chain triglycerides (MCTs) and vegetable fibers on the quality of life of patients with psoriatic arthritis, by monitoring the patients over a period of 3 months in a single-center interventional study. As secondary objectives, the study will assess the effects of the same formulation on disease activity and on certain blood parameters and dietary habits.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

MCTs and fiber

Water-soluble powder containing medium-chain triglycerides, soluble and unsoluble fiber.

OTHER

Placebo powder

Water-soluble powder containing no medium-chain triglycerides and no fiber.

Locations (1)

ASST Gaetano Pini CTO, UOC Clinica Reumatologica

Milan, Italy, Italy