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Type1 DiabetesNCT05766657

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

A study testing Microbiome-targeted diet in people with Type1 Diabetes and Obesity, run by IRCCS San Raffaele at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Type1 Diabetes, Obesity
What is being tested?
Microbiome-targeted diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
2 sitesItaly
Study dates
23 Dec 2022to 24 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Pediatric Unit

    Milan, Milano, 20132

  • Autoimmune Pathogenesis Unit

    Milan, Milan, 20132

Other trials in Italy

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

Randomized, multicenter, 2-arm, parallel-group, single-blind controlled clinical trial (1:1 allocation ratio) with 1 group of patients with obesity (N=20) or type 1 (n=20) treated with standard obesity treatment diet or usual diet (diabetic children) and 1 group (N=20 for obesity and (N=20 for type 1 diabetes) treated with the same diets to which nutritional advice derived from microbiota analysis (NUTRI-DIET) will be added.

The study will last 12 months with an intervention phase (personalized diet) lasting 3 months.

The research includes an enrollment phase that may extend up to 9 months depending on the number of patients enrolled. The enrollment phase will be considered finished once a total of 80 patients (i.e., 40 pediatric patients with type 1 diabetes and 40 obese pediatric patients) are enrolled. During the patient enrollment phase, relevant clinical information (biological samples as faeces, urines and blood and questionnaires on diet habits, physical activity and stress) will be collected concurrently. Tests will be performed once enrollment is completed on samples from all patients collected at the time of enrollment (microbiota analysis on stool, metabolome analysis on stool and urine, serological gut barrier markers analysis on serum). Obese and/or diabetic children will be randomized to the intervention or control group. Randomization will be done according to age (≤12: >12), gender and pathology (diabetes or obesity).

Being tested
Microbiome-targeted diet, Usual care diet
Keywords
Gut microbiome, Inflammation, Type 1 Diabetes, Obesity, Immunology, Gut barrier, Intestinal barrier, Extra-intestinal diseases
Medical subject headings
Obesity, Inflammation, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microbiome-targeted dietDietary 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.

  • Usual care dietDietary supplement

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

Study groups in NCT05766657
Study groupRoleWhat they receive
Intervention groupExperimentalChildren with obesity or T1D will be randomized into this group. An individualized dietary approach will be used in this group of children.
Receives: Dietary Supplement: Microbiome-targeted diet
Control GroupPlacebo comparatorchildren 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.
Receives: Dietary Supplement: Usual care diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemia

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

    Measured: Up to 3 months

  2. Glycemic control by glycated hemoglobin (HbA1c) monitoring

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

    Measured: Up to 3 months

  3. 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).

    Measured: Up to 3 months

  4. 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).

    Measured: Up to 3 months

Secondary outcomes (2)

  1. Metagenomic analysis

    Changes in gut microbiota composition following personalized microbiome-targeted diet, as assessed by 16S ribosomal RNA (rRNA) sequencing on DNA extracted from patient-derived fecal samples.

    Measured: Up to 3 months

  2. Metabolomic analysis

    Changes in microbiota-derived metabolites following personalized microbiome-targeted diet, as assessed by Mass Spectrometry on patient-derived fecal and urine samples.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start23 Dec 2022
  3. Primary completion24 Nov 2023
  4. Study completion24 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, multicenter, 2-arm, parallel-group, single-blind controlled clinical trial (1:1 allocation ratio)
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05766657
Sponsor's protocol ID
NUTRI-DIET
Status last verified
Jan 2025
First submitted
2 Dec 2022
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Microbiome-targeted diet in people with Type1 Diabetes and Obesity, run by IRCCS San Raffaele at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemia (time frame: Up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05766657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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