Psoriasis
Conditions
Brief summary
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.
Interventions
OTHERDiet
A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
San Giuseppe Moscati Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Psoriasis Area and Severity Index | 10 weeks | Change in score (on continuous scale) at the end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Psoriasis Area and Severity Index >=75% | 10 weeks | Proportion of patients with change in score \>=75% at the end of study |
| Reduction in Psoriasis Area and Severity Index >=50% | 10 weeks | Proportion of patients with change in score \>=50% at the end of study |
| Reduction in body surface area | 10 weeks | Change in body surface area (on continuous scale) involved at the end of study |
| Reduction in Psoriasis Area and Severity Index | 4 weeks | Change in score (on continuous scale) at the end of ketogenic diet-phase |
| Reduction in itch severity | 10 weeks | Change in itch severity (on continuous visual analogue scale) at the end of study |
| Reduction in body weight | 10 weeks | Change in body weight (on continuous scale) at the end of study |
| Reduction in Visceral fat | 10 weeks | Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study |
| Reduction in Dermatology Life Quality Index (DLQI) | 10 weeks | Change in DLQI (on continuous scale) at the end of study |
Countries
Italy
Outcome results
None listed