Aggressive Weight Loss Program in Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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Chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. Besides, clinical improvement has been directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic diets are responsible for substantial weight loss and attenuate systemic inflammation to a higher extent than moderately hypocaloric diets. This intervention has been recently demonstrated to restore, after only 4 week, the response to biological therapy in a patient suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic induction phase in a single-arm trial that could provide the rationale for a large randomized trial.

Official Title
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A Single-arm Trial to Evaluate the Efficacy of an Aggressive Weight Loss Program With a Ketogenic Induction Phase for the Treatment of Chronic Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable chronic plaque psoriasis Overweight/obese (body mass index >25 kg/m2) Exclusion Criteria: pregnancy and/or lactation insulin-dependent diabetes mellitus a psychiatric disorder current or previous (<1 year since last chemo- or radiotherapy) neoplastic disease established vascular disease recent (6 months), history of diet-induced or unintentional weight loss moderate-to-severe heart failure arrhythmia or conduction disorder renal failure (creatinine >1.5 mg/dL) liver failure (Child-Pugh ≥ A) any type of gastrointestinal disease moderate-severe hypoalbuminemia (<3.0 g/dL) altered serum electrolytes refusal to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet | Other: Diet<br>* A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Psoriasis Area and Severity Index | Change in score (on continuous scale) at the end of study | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Psoriasis Area and Severity Index | Change in score (on continuous scale) at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in Psoriasis Area and Severity Index >=75% | Proportion of patients with change in score >=75% at the end of study | 10 weeks | 
| Reduction in Psoriasis Area and Severity Index >=75% | Proportion of patients with change in score >=75% at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in Psoriasis Area and Severity Index >=50% | Proportion of patients with change in score >=50% at the end of study | 10 weeks | 
| Reduction in Psoriasis Area and Severity Index >=50% | Proportion of patients with change in score >=50% at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in body surface area | Change in body surface area (on continuous scale) involved at the end of study | 10 weeks | 
| Reduction in body surface area | Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in Dermatology Life Quality Index (DLQI) | Change in DLQI (on continuous scale) at the end of study | 10 weeks | 
| Reduction in Dermatology Life Quality Index (DLQI) | Change in DLQI (on continuous scale) at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in itch severity | Change in itch severity (on continuous visual analogue scale) at the end of study | 10 weeks | 
| Reduction in itch severity | Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in body weight | Change in body weight (on continuous scale) at the end of study | 10 weeks | 
| Reduction in body weight | Change in body weight (on continuous scale) at the end of ketogenic diet-phase | 4 weeks | 
| Reduction in Visceral fat | Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study | 10 weeks | 
| Reduction in Visceral fat | Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase | 4 weeks |