NCT05766657Completed
Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases
Evaluation of the Effect of an Anti-inflammatory Diet Built on the Basis of the Gut Microbiota in Children with Type 1 Diabetes and Obesity
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
The overall objective of the study is to provide personalized nutritional advice based on the gut microbiota profile of children with type 1 diabetes (T1D) or obesity. Specifically, the primary objective of NUTRI-DIET is to validate a dietary model aimed at restoring bacterial species and/or anti-inflammatory metabolites in order to prevent extra-intestinal diseases characterized by dysbiosis, such as T1D and obesity. The primary endpoints of the study will be to monitor the glycemic control indices, i.e., blood glucose (mean of glycemic values, percentage of time-in-range value (TIR), which will be displayed by glycemic sensor) and glycated hemoglobin for diabetic children and Body mass index (BMI) z-score according to World Health Organization (WHO) recommendations (WHO BMI-for-age boys; WHO BMI-for-age girls) for obese children. The secondary objective of the study is to characterize the microbiota profile of the study patients and to test the algorithm under development built from the integration of diet and and gut microbiota composition data that were obtained during the previous observational study NUTRI-T1D.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 2 Dec 2022
- Start date
- 23 Dec 2022
- Primary completion date
- 24 Nov 2023
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT05766657
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 23 Dec 2022 to the primary completion date, 24 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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)
Other illness
- 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
- Children with specific eating disorders, which may hinder the research results
Other
- Recent weight loss or weight gain (\> 3 kg), (in the 3 months preceding the study)
- Inability (physically or psychologically) to comply with the procedures required by the protocol
Who the study is looking for
- Eligible for participation will be children diagnosed with obesity (BMI \> 95th percentile) and type 1 diabetes aged 8-18 years
- Signature of informed consent
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pediatric Unit Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Autoimmune Pathogenesis Unit Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.