Modified Intermittent Fasting in Psoriasis Trial: a Randomized Controlled Open Crossover Clinical Trial to Investigate the Effects of a Dietary Intervention on the Gut-skin Axis in Patients with Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
研究概览
简要总结
The complexity of psoriasis is partially affected by dietary effects, and some diets have shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with psoriasis have been reported to have impaired intestinal integrity and it has been suggested that gut health affects skin health, pointing towards a gut-skin axis. Understanding how dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly improve our understanding on the development of psoriasis. Modified intermittent fasting (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect on gut and skin remains underexplored.
详细描述
To study the role of gut health, more specifically the intestinal barrier, in individuals with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over study. The investigators will test whether MIF can improve (i) skin lesions (clinical and molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and (iii) the timing of these improvements. As such, it can be determined whether fasting benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating between MIF and usual diet).
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
- Single (Outcomes Assessor)
盲法说明
Skin severity will be assessed by blinded physician for quantification of Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild psoriasis (PASI < 10)
- •At least BMI of 20
- •Stable weight for last 3 months
- •Topical treatment
- •Availability of smartphone and willing to install app
- •Willing to attend dematology clinic at Ghent University Hospital
排除标准
- •Underweight and/or following strict diet
- •Use of anti, pre and/or probiotics (last 3 months)
- •Use of immunosuppressants (last 3 months)
- •Consumption of fish oil
- •Diagnosed diabetes (type ½)
- •Excessive physical activity
- •Pregnancy or breastfeeding
- •More than 14 alcohol units/week
- •History of cardiac condition(s)
研究组 & 干预措施
MIF-regular
MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.
干预措施: Modified Intermittent Fasting followed by Regular Diet (Behavioral)
Regular-MIF
Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.
干预措施: Regular Diet followed by Modified Intermittent Fasting (Behavioral)
结局指标
主要结局
Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
时间窗: 12 and 26 weeks
Change in Psoriasis Area Severity Index
Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
时间窗: 12 and 26 weeks
Change in Body Surface Area
次要结局
- Weight during and after intervention to baseline(12 and 26 weeks)
- Total body fat during and after intervention to baseline(12 and 26 weeks)
- Body Mass Index during and after intervention to baseline(12 and 26 weeks)
- Waist circumference during and after intervention to baseline(12 and 26 weeks)
- Inflammation markers in serum during and after intervention to baseline(12 and 26 weeks)
- Inflammation markers in skin during and after intervention to baseline(12 and 26 weeks)
- Metabolic markers in serum during and after intervention to baseline(12 and 26 weeks)
- Metabolic markers in skin during and after intervention to baseline(12 and 26 weeks)
- Permeability markers in serum during and after intervention to baseline(12 and 26 weeks)
- Prediction of dietary intake(12 and 26 weeks)
- Permeability markers in feces during and after intervention to baseline(12 and 26 weeks)
- Visual Analogue Scale Satisfaction(12 and 26 weeks)
- Study completion by subjects(12 and 26 weeks)
- Quality of life during and after intervention to baseline(12 and 26 weeks)