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
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedStudy Start
First participant enrolled
May 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2018
CompletedOctober 31, 2018
October 1, 2018
5 months
April 4, 2018
October 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in Psoriasis Area and Severity Index
Change in score (on continuous scale) at the end of study
10 weeks
Secondary Outcomes (15)
Reduction in Psoriasis Area and Severity Index
4 weeks
Reduction in Psoriasis Area and Severity Index >=75%
10 weeks
Reduction in Psoriasis Area and Severity Index >=75%
4 weeks
Reduction in Psoriasis Area and Severity Index >=50%
10 weeks
Reduction in Psoriasis Area and Severity Index >=50%
4 weeks
- +10 more secondary outcomes
Study Arms (1)
Experimental
EXPERIMENTALA 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Interventions
A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Eligibility Criteria
You may qualify if:
- Stable chronic plaque psoriasis
- Overweight/obese (body mass index \>25 kg/m2)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.O.R.N. "San Giuseppe Moscati"
Avellino, Italy
Related Publications (4)
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.
PMID: 26559897BACKGROUNDCastaldo 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.
PMID: 27193396BACKGROUNDCastaldo 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.
PMID: 26044613BACKGROUNDMonaco 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.
PMID: 24366220BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Castaldo, MD
A.O.R.N. "San Giuseppe Moscati", Avellino, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 4, 2018
First Posted
May 21, 2018
Study Start
May 21, 2018
Primary Completion
October 29, 2018
Study Completion
October 29, 2018
Last Updated
October 31, 2018
Record last verified: 2018-10