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

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.

Eligibility

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.

Conditions2

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