NCT03142503已完成不适用
Effectiveness of a Dietary Intervention Program on Disease Activity, Metabolism and Oxidative Stress in Patients With Psoriatic Arthritis and Psoriasis Activity: A Clinical, Randomized, Placebo-controlled Trial
Federal University of São Paulo0 个研究点目标入组 194 人开始时间: 2013年1月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 主要终点
- Disease activity
研究概览
简要总结
Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and inflammation are also contributing mechanisms on Ps and PsA. However, little is known about the influence of diet and micronutrients on the main outcomes of these diseases. The aim of the investigators is to evaluate the effectiveness of an intervention diet program on disease activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)
排除标准
- •lack of written informed consent;
- •age < 18 years old;
- •history of gastrointestinal, endocrine, pulmonary, kidney, hepatic, and neuromuscular diseases, as well as HIV-positive;
- •pregnant or breast-feeding women;
- •previous history of cancer;
- •use of steroids, protein supplements, vitamins, multivitamins, or antioxidants.
- •Specific medications to PsA and physical activity were required to be stable for the last 3 months to be included in the study
结局指标
主要结局
Disease activity
时间窗: 12 weeks
To evaluate the increase of Minimal Disease Activity (MDA) after intervention
次要结局
- Glycation markers(12 weeks)
- Lean Mass(12 weeks)
- Waist circumference(12 weeks)
- Lipidic Peroxidation(12 weeks)
- Body Mass Index(12 weeks)
- Inflammatory markers(12 weeks)
- Fat Mass(12 weeks)
- Anti-inflammatory marker(12 weeks)
- Cutaneous activity(12 weeks)
- Articular activity(12 weeks)
研究者
Marcelo M Pinheiro
Assistant Professor
Federal University of São Paulo
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