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NCT05766657
Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases
NA trial testing Microbiome-targeted diet in Type1 Diabetes in 39 participants. Completed in 24 November 2023.
24 November 2023
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 23 December 2022 |
| Primary completion | 24 November 2023 |
| Estimated completion | 24 November 2023 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Microbiome-targeted diet
- Usual care diet
Conditions studied
- Type1 Diabetes — all drugs for Type1 Diabetes →
- Obesity — all drugs for Obesity →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
Adults 8 to 18, any sex, with Type1 Diabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05766657
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type1 Diabetes
Currently open trials in the same condition.
- NCT06408207 — CGM Academy for Youth With Type 1 Diabetes · NA · recruiting
Other IRCCS San Raffaele trials
Trials by the same sponsor.
- NCT07454759 — Acute Sarcopenia in Hospitalized Older Adults · not yet recruiting
- NCT07456462 — Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance · NA · not yet recruiting
- NCT07066878 — This Protocol Focuses on the Factors That Influence Survival, the Development of Complications and the Quality of Life B · not yet recruiting
- NCT07526298 — Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Ap · not yet recruiting
- NCT07426471 — Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections. · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05766657 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
- Last refreshed: 23 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05766657.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing