CompletedPhase 4

n-3 Polysaturated Fatty Acids-rich Diet in Psoriasis

Italy44 participantsStarted 2007-04

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * diabetes, * malignancy, * history of food intolerance or autoimmune disorders, * patients non-collaborative

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite outcome of Metabolic markers

Timeframe: 6 months

Composite outcome of Anthropometric measurements

Timeframe: 6 months

Composite outcome of Clinical assessments

Timeframe: 6 months

Composite outcome of Dietary assessment

Timeframe: 6 months

Trial details

NCT IDNCT01876875

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-10

View on ClinicalTrials.gov More Plaque-type Psoriasis trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.