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

NCT06990152 | Completed

• 1 other identifier: CALIPSO-2025
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Psoriatic Arthritis (PsA)

Keywords

medium-chain triglycerides; dietary fiber; psoriatic arthritis; CALIPSO

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  Improvement in the health-related quality of life as perceived by patients (measured using the EuroQol-5 Dimensions-5 Levels, EQ-5D-5L, questionnaire) from baseline (T0) to the end of the study (T2) in the Test group compared to the Control group. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems, moderate problems, severe problems and extreme problems (5). The EQ-5D-5L Index Score is derived from the descriptive system using country-specific value sets. These scores typically range from \<0 (worse than death) to 1 (full health). For example, in many value sets, the minimum score can be around -0.59, and the maximum score is 1.00. The EQ VAS score ranges from 0 to 100, as self-reported by the patient.

  baseline (T0), month 1 (T1), month 2 (T2) and month 3 (T3)

Secondary Outcomes (5)

• Impact of the disease on patient's life

  baseline (T0), month 1 (T1), month 2 (T2) and month 3 (T3)

• Physical and mental health status

  baseline (T0), month 1 (T1) and month 2 (T2)

• Lipid profile

  baseline (T0), month 1 (T1) and month 2 (T2)

• Dietary habits

  baseline (T0), month 1 (T1) and month 2 (T2)

• Bioelectrical Impedance Analysis (BIA)

  baseline (T0), month 1 (T1) and month 2 (T2)

Study Arms (2)

Control placebo group

PLACEBO COMPARATOR

Patients assigned to this group will consume a placebo powder.

Other: Placebo powder

MCTs and fiber group (Test group)

EXPERIMENTAL

Patients assigned to this group will consume twice per day a portion of MCTs and fiber.

Other: MCTs and fiber

Interventions

MCTs and fiber OTHER

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

MCTs and fiber group (Test group)

Placebo powder OTHER

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

Control placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Schär AG / SPA: lead
• ASST Gaetano Pini-CTO: collaborator

Study Sites (1)

ASST Gaetano Pini CTO, UOC Clinica Reumatologica

Milan, Italy, 20122, Italy

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Francesca Ingegnoli, Professor

  ASST Gaetano Pini CTO, UOC Clinica Reumatologica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: May 16, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)