Status:
RECRUITING
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
Lead Sponsor:
Dr. Schär AG / SPA
Collaborating Sponsors:
ASST Gaetano Pini-CTO
Conditions:
Psoriatic Arthritis (PsA)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 arth...
Detailed Description
The diagnostic and therapeutic framework in the field of psoriatic arthritis (PsA) is complex and not yet fully defined. Despite significant advances in pharmacological therapy and although particular...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06990152
Start Date
May 16 2025
End Date
December 1 2025
Last Update
May 29 2025
Active Locations (1)
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1
ASST Gaetano Pini CTO, UOC Clinica Reumatologica
Milan, Italy, Italy, 20122