Investigating the link between obesity and infectious diseases with diet and melatonin
PRIN "SIDERALE": Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation
This study is testing how obesity affects the risk of getting infections and whether a Mediterranean diet and melatonin can help people with obesity and related health issues feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 4 sites (Naples and 3 other locations) |
| Trial ID | NCT06236932 on ClinicalTrials.gov |
What this trial studies
This project explores how obesity affects susceptibility to infectious diseases and the potential benefits of a Mediterranean diet and melatonin supplementation. It aims to enroll patients with essential and genetic forms of obesity, as well as those with obesity-related conditions like Type 2 diabetes and lipodystrophy. The study will assess the relationship between dietary habits, gut microbiota, and infection rates, while also examining the impact of lifestyle factors on health outcomes. Structured questionnaires will be used to gather data on biomedical values and environmental conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with a BMI of 30-35 kg/m2, including those with essential obesity, genetic obesity, or obesity-related conditions.
Not a fit: Patients who are pregnant, breastfeeding, or have severe health conditions such as cardiac or liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary and treatment strategies for obese patients to reduce their risk of infections.
How similar studies have performed: While the role of diet and melatonin in obesity has been explored, this specific approach to linking these factors with infectious disease susceptibility is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * essential obesity (BMI : 30-35 Kg/m2) * genetic forms of obesity (BMI: 30-35 Kg/m2) * obesity (BMI:30-35 Kg/m2) associated with T2DM * obesity (BMI:30-35 Kg/m2) associated with endocrinopathies * lipodystrophy Exclusion Criteria: * pregnancy, breast-feeding, alcohol and drug abuse, known severe haematological, cardiac, liver, kidney, mental diseases, hypogonadisms, hormonal treatments including estroprogestins, intolerance to melatonin or excipients
Where this trial is running
Naples and 3 other locations
- "Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology — Naples, Italy (Recruiting)
- Università del Piemonte Orientale — Novara, Italy (Recruiting)
- University of Pisa — Pisa, Italy (Recruiting)
- "Sapienza" University of Rome — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Annamaria Colao, Prof — Federico II University
- Study coordinator: Annamaria Colao, Prof
- Email: colao@unina.it
- Phone: +393285390000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.