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| Name | Class |
|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Psoriasis Area and Severity Index | Change in score (on continuous scale) at the end of study | 10 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Castaldo, MD | A.O.R.N. "San Giuseppe Moscati", Avellino, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.R.N. "San Giuseppe Moscati" | Avellino | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26559897 | Background | Castaldo G, Galdo G, Rotondi Aufiero F, Cereda E. Very low-calorie ketogenic diet may allow restoring response to systemic therapy in relapsing plaque psoriasis. Obes Res Clin Pract. 2016 May-Jun;10(3):348-52. doi: 10.1016/j.orcp.2015.10.008. Epub 2015 Nov 11. | |
| 27193396 | Background | Castaldo G, Monaco L, Castaldo L, Galdo G, Cereda E. An observational study of sequential protein-sparing, very low-calorie ketogenic diet (Oloproteic diet) and hypocaloric Mediterranean-like diet for the treatment of obesity. Int J Food Sci Nutr. 2016 Sep;67(6):696-706. doi: 10.1080/09637486.2016.1186157. Epub 2016 May 18. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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 |
| 26044613 | Background | Castaldo G, Palmieri V, Galdo G, Castaldo L, Molettieri P, Vitale A, Monaco L. Aggressive nutritional strategy in morbid obesity in clinical practice: Safety, feasibility, and effects on metabolic and haemodynamic risk factors. Obes Res Clin Pract. 2016 Mar-Apr;10(2):169-77. doi: 10.1016/j.orcp.2015.05.001. Epub 2015 Jun 1. |
| 24366220 | Background | Monaco L, Monaco M, Di Tommaso L, Stassano P, Castaldo L, Castaldo G. Aortomesenteric fat thickness with ultrasound predicts metabolic diseases in obese patients. Am J Med Sci. 2014 Jan;347(1):8-13. doi: 10.1097/MAJ.0b013e318288f795. |