A Randomized, Double-blind Clinical Trial on the Efficacy of a Dietary Formulation Containing Med… (NCT06990152) | Clinical Trial Compass
CompletedNot Applicable
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
Italy72 participantsStarted 2025-05-16
Plain-language summary
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 can participate
Age range18 Years – 80 Years
SexALL
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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.