The Effect of Ketogenic Diet Versus Mediterranean Diet on Clinical and Biochemical Markers of Inflammationand in Patients With Obesity and Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Psoriasis Area and Severity Index score
研究概览
简要总结
The aim of our study is to compare the effectiveness of Mediterranean diet (MD) with the isocaloric Ketogenic diet (KD) on clinical and biochemical markers of inflammation in patients with obesity, psoriasis (PSO) and psoriatic arthritis (PsA).
详细描述
Overall, twenty patients with body mass index (BMI) >30 kg/m2, PSO and PsA under constant systematic treatment for at least 3 months will be included in the study. They will randomly assign to two groups, starting either with MD or KD for a period of 8 weeks. After a 6-week washout interval, the two groups will cross over to the other type of diet for the same 8-week period. The primary endpoint is the change in Psoriasis Area and Severity Index (PASI) and the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention. Secondary endpoints are changes in biochemical markers of inflammation (IL-6, IL-17, IL-22, IL-23) , in metabolic and anthropometric parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 18 years
- •body mass index (BMI) >30 kg/m2
- •diagnosis of psoriasis and psoriatic arthritis under constant systematic treatment with biologic agents and/or synthetic disease-modifying anti-rheumatic drugs (DMARDs) for at least 3 months.
- •ΔPASI SCORE<75, with moderate or severe activity in joints ( > 3 swollen &> 3 tender joints ή DAPSA< 14).
排除标准
- •participation in another study
- •eGFR<60ml/min/1.73m2
- •severe hepatic disorder
- •use of glucagon-like-petide-1 analogues
结局指标
主要结局
Psoriasis Area and Severity Index score
时间窗: eight weeks
The primary endpoint is changes in Psoriasis Area and Severity Index (PASI), 8 weeks after each diet intervention.(score range: 0-72; higher scores indicate more severe disease).
Disease Activity Index for Psoriatic Arthritis score
时间窗: eight weeks
The primary endpoint is changes in Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention.(DAPSA\<4: remission, DAPSA 4-14: low disease activity, DAPSA:14-28:moderate disease activity, DAPSA\>28: high disease activity)
次要结局
- Interleukin-6(eight weeks)
- Interleukin-17(eight weeks)
- Interleukin-22(eight weeks)
- Interleukin-23(eight weeks)
- Glucagon Like Peptide-1(eight weeks)
- Oxyntomodulin(eight weeks)
- Peptide YY(eight weeks)
- Ghrelin(eight weeks)
研究者
VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Attikon Hospital