Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01714284

Enrollment

303

Registered

2012-10-25

Start date

2011-02-28

Completion date

2012-01-31

Last updated

2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

psoriasis

Brief summary

This is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.

Interventions

BEHAVIORALInformative

The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.

BEHAVIORALDiet and Exercise

The intervention consists in a 20 weeks quantitative and qualitative dietary plan for weight loss associated with physical exercise. The plan will be developed with the help of qualified staff (Dieticians) and elaborated in relation to individual needs of the patient.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of chronic plaque psoriasis * BMI \> 25 Kg/m² * Patients under systemic treatments for psoriasis or candidates for such treatments

Exclusion criteria

* Diagnosis of other type of psoriasis or psoriatic arthritis * Patients under local treatments or candidates for such treatments * Patients expected to have poor compliance at follow-up evaluation

Design outcomes

Primary

Measure	Time frame
Any change from baseline of PASI index	20 weeks

Secondary

Measure	Time frame
Percent change from baseline of PASI index equal to 100% (PASI100)	8 weeks, 16 weeks, 20 weeks
Any change from baseline of PASI index	8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)	8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of waist circumference	8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)	8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of Body Mass Index (BMI)	8 weeks, 16 weeks, 20 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026