Aggressive Weight Loss Program in Chronic Plaque Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Avellino, Italy
    • A.O.R.N. "San Giuseppe Moscati"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: San Giuseppe Moscati Hospital
• Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Giuseppe Castaldo, MD, A.O.R.N. "San Giuseppe Moscati", Avellino, Italy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2018
• Primary Completion (ACTUAL): October 29, 2018
• Study Completion (ACTUAL): October 29, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Body Weight; Skin Diseases, Papulosquamous; Body Weight Changes; Psoriasis; Weight Loss
• Other Study ID Numbers: CECN/134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No