Investigating the link between obesity and infectious diseases with diet and melatonin
Official title: PRIN "SIDERALE": Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation
Run by Federico II University · NCT06236932 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Federico II University Academic / other |
| Locations | 4 sites (Naples and 3 other locations) |
| Status | Recruiting |
| Started | December 29, 2023 |
| Main results expected | October 29, 2025 |
| Study ends | October 29, 2026 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT06236932 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
"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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Improving heart health for low-income individuals with diabetes and obesity
This study is testing whether a 6-month program that includes training, exercise help, and community support can improve heart health for low-income people with diabetes and obesity compared to regular education and exercise access.
-
Lowering liver fat in people with type 2 diabetes
This trial will try a two-week very-low-calorie diet to see if lowering liver fat restores exercise-induced FGF21 secretion in people with type 2 diabetes.
-
Investigating gut microbiota in obese patients with type 2 diabetes and infections
This study looks at how the bacteria in the gut of obese adults with type 2 diabetes might affect their chances of getting chronic infections.
-
Comparing the effects of bariatric arterial embolization and gastric bypass on obesity and diabetes
This study is testing whether a new procedure called bariatric arterial embolization can help people with obesity and Type 2 diabetes just as well as the traditional gastric bypass surgery.
-
Ocular Changes in People Using Tirzepatide or Semaglutide
This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.
-
Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes
This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.