Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases
Type1 Diabetes, Obesity
About this trial
This is an interventional treatment trial for Type1 Diabetes focused on measuring Gut microbiome, Inflammation, Type 1 Diabetes, Obesity, Immunology, Gut barrier, Intestinal barrier, Extra-intestinal diseases
Eligibility Criteria
Inclusion Criteria: Eligible for participation will be children diagnosed with obesity (BMI > 95th percentile) and type 1 diabetes aged 8-18 years Signature of informed consent Exclusion Criteria: Children with any acute or chronic disease (cancer, infection, other), gastrointestinal disease, cardiovascular disease, chronic kidney disease, parathyroid disease, diseases requiring regular phlebotomies, and other chronic diseases that could affect the results of the present study Taking medications other than insulin, including hypolipidemic and antihypertensive drugs Use of medications that could affect the results of the study, including systemic glucocorticoids and antibiotics (in the three months prior to the study) Recent weight loss or weight gain (> 3 kg), (in the 3 months preceding the study) Blood transfusion in the last 3 months prior to blood sampling Use of dietary supplements, including multivitamins, fish oil capsules, minerals and trace elements (three months prior to and throughout the study period) Inability (physically or psychologically) to comply with the procedures required by the protocol Children with specific eating disorders, which may hinder the research results
Sites / Locations
- Pediatric UnitRecruiting
- Autoimmune Pathogenesis UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention group
Control Group
Children with obesity or T1D will be randomized into this group. An individualized dietary approach will be used in this group of children.
children assigned to the control group will receive generic advice based on European dietary guidelines for obesity or follow their usual diet in the case of children with T1D.