Trial Clinico Randomizzato e Doppio-cieco Sull'Efficacia di Una Formulazione Alimentare Contenente Trigliceridi a Media Catena (MCT) e Fibre in Pazienti Con Artrite Psoriasica
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control placebo group
Patients assigned to this group will consume a placebo powder.
干预措施: Placebo powder (Other)
MCTs and fiber group (Test group)
Patients assigned to this group will consume twice per day a portion of MCTs and fiber.
干预措施: MCTs and fiber (Other)
结局指标
主要结局
Health-related quality of life
时间窗: baseline (T0), month 1 (T1), month 2 (T2) and month 3 (T3)
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.
次要结局
- Dietary habits(baseline (T0), month 1 (T1) and month 2 (T2))
- 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))
- Bioelectrical Impedance Analysis (BIA)(baseline (T0), month 1 (T1) and month 2 (T2))