Role of Nutritionist in the Multidisciplinary Approach of Hidradenitis Suppurativa (Acne Inversa)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Primary Endpoint
- Trimethylamine N-oxide plasma levels
Study Overview
Brief Summary
Hidradenitis suppurativa (HS) is a chronic inflammatory, debilitating skin disorder. The exacerbating factors of HS include nutrition and adiposity. The objective of this study was to investigate the relationships between body composition and the adherence to the Mediterranean diet (MD) with the severity of HS in a sample of naïve-treatment patients with HS. In the wake of this evidence, in the study to investigate the relationships between nutritional status, the adherence to the MD, body composition, and the severity of HS in a sample of naïve-treatment patients with HS compared to control group matched for sex, age, and body weight.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy subjects of both gender
- •treatment-naïve patients
- •had HS diagnosed ≥6 months before study initiation wash out therapy for at least 3 months
Exclusion Criteria
- •occasional or current of use of drugs for HS, including topical antibiotics and systemic treatments (such as clindamycin-rifampicin, tetracycline, Rifampicin-moxifloxacin-metronidazole, ertapenem, acitretin, cyclosporine A, dapsone, isotretinoin, biologics;
- •hypocaloric diet in the last three months or specific nutritional regimens;
- •vitamin/mineral or antioxidant supplementation;
- •occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy.
Outcomes
Primary Outcomes
Trimethylamine N-oxide plasma levels
Time Frame: April 2015 to April 2018
ultra high-performance liquid chromatography
Adherence to Mediterranean Diet by Predimed Questionnaire
Time Frame: April 2015 to April 2018
Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (≤5, low adherence, 6-9, average adherence and ≥10 points, high adherence)
Phase angle
Time Frame: April 2015 to April 2018
Phase angle was performed using a BIA phase-sensitive system by experienced observers (an 800-µA current at a frequency single-frequency of 50 kHz BIA 101 RJL, Akern Bioresearch, Florence, Italy).
Secondary Outcomes
- Vitamin D(April 2015 to April 2018)
Investigators
Prof. Silvia Savastano
Associate Professor
Federico II University