Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases

NCT05766657 | Completed DMC

• 1 other identifier: NUTRI-DIET
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type1 Diabetes; Obesity

Keywords

Gut microbiome; Inflammation; Type 1 Diabetes; Obesity; Immunology; Gut barrier; Intestinal barrier; Extra-intestinal diseases

Outcome Measures

Primary Outcomes (4)

• Glycemia

  Blood glucose levels (mg/dL) will be measured in diabetic children.

  Up to 3 months

• Glycemic control by glycated hemoglobin (HbA1c) monitoring

  The percentage of glycated hemoglobin (HbA1c, %) in the blood will be measured in diabetic children.

  Up to 3 months

• Glycemic control by Time-in-Range (TIR) monitoring

  TIR values - that is the percentage of time in which blood glucose (blood sugar) remains in the safe target range of 70-180mg/dL - will be monitored in diabetic children by extracting the recorded data from the continuous glucose monitoring (CGM) device (sensor).

  Up to 3 months

• Body mass index (BMI)

  The BMI z-score in obese children will be measured, according to WHO recommendations (WHO BMI-for-age boys; WHO BMI-for-age girls).

  Up to 3 months

Secondary Outcomes (2)

• Metagenomic analysis

  Up to 3 months

• Metabolomic analysis

  Up to 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Children with obesity or T1D will be randomized into this group. An individualized dietary approach will be used in this group of children.

Dietary Supplement: Microbiome-targeted diet

Control Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Usual care diet

Interventions

Microbiome-targeted diet DIETARY_SUPPLEMENT

The gut microbiota (on stool) and metabolic profile (on stool and urine) will be analyzed at time 0, and the dietary plan will contain specific directions aimed at restoring a proper metagenomic and metabolomic profile of the microbiota.

Intervention group

Usual care diet DIETARY_SUPPLEMENT

Subjects on the control group will receive general dietetic advice for Obesity or T1D

Control Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Eligible for participation will be children diagnosed with obesity (BMI \> 95th percentile) and type 1 diabetes aged 8-18 years
• Signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (2)

Pediatric Unit

Milan, Milano, 20132, Italy

Location

Autoimmune Pathogenesis Unit

Milan, Milan, 20132, Italy

Location

MeSH Terms

Conditions

Obesity; Inflammation; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Single blind: Apart from clinical nutritionists who will be involved in dietary counseling, physicians and all project staff who will be responsible for patient selection and follow-up, along with biostatisticians, will be blinded to the intervention groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, multicenter, 2-arm, parallel-group, single-blind controlled clinical trial (1:1 allocation ratio)

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: March 13, 2023
• Study Start: December 23, 2022
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)