n-3 Polysaturated Fatty Acids-rich Diet in Psoriasis

NCT01876875 | Completed Phase 4 DMC

• 2 other identifiers: Cataldi13CAT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Low-grade systemic inflammation associated with obesity may worsen the clinical course of psoriasis. Both a low-calorie diet and nutritional supplementation have been shown to have an impact on the clinical course of psoriasis, including an anti-inflammatory effect of n-3 polyunsaturated fatty acids (PUFAs). This study aimed to assess the effectiveness of an energy-restricted diet, enriched in n-3 PUFAs and poor in n-6 PUFAs, on metabolic markers and clinical outcome of obese patients with psoriasis. Methods: Forty-four obese patients with mild-to-severe plaque-type psoriasis treated with immuno-suppressive drugs were randomized to assume either their usual diet or an energy-restricted diet (20 kcal/kg/ideal body weight/day) enriched of n-3 PUFAs (average 2.6 g/d). All patients continued their immuno-modulating therapy throughout the study. End-point measures included anthropometric, biochemical and clinical parameters at baseline, 3 and 6 months.

Conditions

Plaque-type Psoriasis; Obesity (Body Mass Index >30 kg/m2)

Keywords

psoriasis; obesity

Outcome Measures

Primary Outcomes (4)

• Composite outcome of Metabolic markers

  Fasting blood samples were drawn for the following measurements: serum total cholesterol, HDL-cholesterol (HDL-C), LDL-C, triglycerides, fibrinogen and serum glucose. Serum LDL-C concentration was calculated using the Friedewald equation.

  6 months

• Composite outcome of Anthropometric measurements

  BMI was calculated as the ratio of body weight to height2 (kg/m2). Waist circumference was measured with an inelastic tape, the subject in standing position, at the level of the umbilicus. According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) criteria,abdominal obesity was defined as waist circumference ≥102 cm in men and ≥88 cm in women

  6 months

• Composite outcome of Clinical assessments

  Clinical assessment was based on three separate instruments: Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and VAS for subjective itch ratings. The PASI is used for measuring psoriasis severity. The scale evaluates four areas of the body (head/neck, upper limbs, trunk, and lower limbs) for erythema, scaliness and thickness of psoriatic plaques. The PASI score can range from 0 to 72, with higher scores indicating greater severity. The DLQI is a self-rated instrument consisting of ten items related to the ways that skin disease may impact a patient's health-related quality of life (HRQL). Scores are based on six subscales and has a possible range 0 to 30, with 30 corresponding to the worst HRQL. Subjective itch ratings were recorded using a computerized VAS, anchored by the terms "no itching" (0 points) and "severe itching" (10 points). Subjects were asked to respond in terms of their itching "at the present time".

  6 months

• Composite outcome of Dietary assessment

  Dietary compliance was evaluated by experienced dietitians trained for this project, using a combination of food diaries, personal interviews and a detailed food-frequency questionnaire that included 130 foods and beverages. Information on diet included weekly frequency of consumption and portion size. Average daily intakes were calculated by using food tables and industry estimates of the n-3 naturally-rich margarine. Total dietary n3 PUFAs refers to the intake of ALA in addition to of long-chain EPA and DHA.

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The patients of this group were randomized to receive an energy-restricted diet (20 kcal/kg/ideal body weight/day) enriched of n-3 PUFAs (average 2.6 g/d).

Dietary Supplement: Energy-restricted, n-3 polysaturated fatty acids-rich diet

Control group

ACTIVE COMPARATOR

The participants of this group are randomized to receive drug therapy alone, continuing their usual diet

Dietary Supplement: Usual diet

Interventions

Energy-restricted, n-3 polysaturated fatty acids-rich diet DIETARY_SUPPLEMENT

The active diet aimed to reduce body weight, to enhance the total intake of n-3 PUFA and to decrease the total intake of n-6 PUFAs. The diet plan was designed to supply an energy intake of 20 kcal/kg/day to maintain an ideal body weight, and followed the guidelines of the American Heart Association (AHA) 'Step-One' Diet: Carbohydrates (mainly complex carbohydrates) and protein constituted of 50-60% and 10-20% of total calories, respectively, and total fat did not exceed 30% of calories. Food values for energy and nutrients were taken from the tables of the Italian National Institute of Nutrition, Souci's Food Composition and Nutrition Tables and the European Institute of Oncology. For long-term and practical daily eating habits, it was important to easily incorporate and consume a variety of selected foods.

Intervention group

Usual diet DIETARY_SUPPLEMENT

The patients of this group were randomized to continue their usual diet

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• body mass index (BMI) \>30 kg/m2,
• age ≥18 years
• clinical diagnosis of plaque-type psoriasis,
• mild-to-severe psoriasis clinically stable for at least 5 months
• no change in psoriasis therapies for at least five months

You may not qualify if:

• diabetes,
• malignancy,
• history of food intolerance or autoimmune disorders,
• patients non-collaborative

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

federico II University

Naples, Naples, 80129, Italy

Location

Related Publications (1)

• Guida B, Napoleone A, Trio R, Nastasi A, Balato N, Laccetti R, Cataldi M. Energy-restricted, n-3 polyunsaturated fatty acids-rich diet improves the clinical response to immuno-modulating drugs in obese patients with plaque-type psoriasis: a randomized control clinical trial. Clin Nutr. 2014 Jun;33(3):399-405. doi: 10.1016/j.clnu.2013.09.010. Epub 2013 Sep 28.

  PMID: 24120032 DERIVED

MeSH Terms

Conditions

Obesity; Psoriasis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 13, 2013
• Study Start: April 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 13, 2013

Record last verified: 2008-10

Locations

IT (1)