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| Name | Class |
|---|---|
| ASST Gaetano Pini-CTO | OTHER |
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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.
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 particularly satisfactory results can be achieved thanks to new-generation DMARDs (disease-modifying antirheumatic drugs), there is still a significant gap regarding factors that, in addition to pharmacological therapy, could help patients further improve their health status, primarily dietary habits.
The aim of this study is to evaluate the effectiveness of a special medical food based on MCTs and fiber in improving quantitative and qualitative parameters in patients with PsA under stable pharmacological treatment and with low disease activity. Specifically, this will be achieved through the analysis of health-related quality of life as perceived by patients, the impact of the disease on general life, body composition and sarcopenia, physical and mental health status of patients, dietary habits, and through an evaluation of metabolic and inflammatory blood parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control placebo group | Placebo Comparator | Patients assigned to this group will consume a placebo powder. |
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| MCTs and fiber group (Test group) | Experimental | Patients assigned to this group will consume twice per day a portion of MCTs and fiber. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCTs and fiber | Other | Water-soluble powder containing medium-chain triglycerides, soluble and unsoluble fiber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the disease on patient's life | Improvement in the impact of the disease on the patient's general life (measured using the Psoriatic Arthritis Impact of Disease 12-item questionnaire, PSAID-12) from baseline to T2 in the Test group compared to the Control group. The questionnaire includes 12 items, each representing a different domain affected by PsA, such as:
Lower scores indicate better health status and lower disease impact. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesca Ingegnoli, Professor | ASST Gaetano Pini CTO, UOC Clinica Reumatologica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Gaetano Pini CTO, UOC Clinica Reumatologica | Milan | Italy | 20122 | Italy |
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| Placebo powder | Other | Water-soluble powder containing no medium-chain triglycerides and no fiber. |
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| baseline (T0), month 1 (T1), month 2 (T2) and month 3 (T3) |
| Physical and mental health status | Changes in physical and mental health status (measured using Health Assessment Questionnaires, HAQ) from baseline to T2 in the Test group compared to the Control group. The Health Assessment Questionnaire Disability Index (HAQ-DI) is a widely used tool to assess functional ability in patients with rheumatic diseases, especially rheumatoid arthritis and psoriatic arthritis. The questionnaire includes 8 domains of daily living activities:
If a patient uses an assistive device or needs help from another person, the minimum score for that domain is 2, unless the score is already 2 or higher. For each domain, the highest score among the questions is taken as the domain score. The HAQ-DI score is the average of the 8 domain scores. | baseline (T0), month 1 (T1) and month 2 (T2) |
| Lipid profile | Changes in the lipid profile of patients (in terms of cholesterol, LDL, HDL, triglycerides) between T-1 and T2 in the Test group compared to the Control group. | baseline (T0), month 1 (T1) and month 2 (T2) |
| Dietary habits | Changes in patients' dietary habits (assessed using the Food Frequency Questionnaire Osservatorio Grana Padano) from baseline to T2 in the Test group compared to the Control group. | baseline (T0), month 1 (T1) and month 2 (T2) |
| Bioelectrical Impedance Analysis (BIA) | Changes in body composition from baseline to T2 in the Test group compared to the Control group. Bioelectrical Impedance Analysis (BIA) will be used to measure changes in body composition. BIA is a non-invasive, quick, and widely used method to estimate body composition, particularly:
| baseline (T0), month 1 (T1) and month 2 (T2) |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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