Taking people in United StatesNo phase

Tests a ketogenic diet in children newly diagnosed with type 1 diabetes

Compares a ketogenic diet with a standard diet in children with new type 1 diabetes.

Key facts

Who runs it: Boston Children's Hospital
Where: Boston, United StatesSee the site
Trial code: NCT05899166
Registry title: Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
Status: Recruiting
People taking part: 52 people, planned
Started: 31 May 2024
Expected to end: 30 Apr 2029
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Ketogenic diet, food delivery and education
Standard diet, food delivery and education
Record updated: 24 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 5 to 12 with newly diagnosed type 1 diabetes. It compares a ketogenic diet with a standard diet for 9 months.

Age: 5 to 12 years
Sex: All sexes
Disease stage: Type 1 diabetes diagnosed within the last 3 months, confirmed by an immediate need for insulin plus at least 2 other criteria (autoimmunity marker, age under 10 years, BMI below the 95th percentile). If joining 2 or more months after diagnosis, insulin adjusted HbA1c must be 9 or lower.
Biomarker or test result: Autoimmunity markers (glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin) count as one of the ways to confirm type 1 diabetes.

Main reasons for not taking part

Eating needs or habits that do not fit the study meal plans (for example vegan, major food intolerances or allergies, already on a ketogenic diet)
Eating disorders, checked with the Chede-Q8
Major medical illness, or medicines other than insulin that could affect blood sugar or metabolism
Major psychiatric illness

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

Children aged 5 to 12 years
Within 3 month of diabetes diagnosis
Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis
Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker [glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin [prior to first insulin dose]; age under 10 years, BMI <95th percentile
Family committed and able to participate in study education and implement dietary intervention

Who cannot take part

Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic)
Eating disorders as assessed by Chede-Q8
Major medical illness or use of medications other than insulin that could interfere with metabolic or glycemic variables
Major psychiatric illness

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 5 and 12 years old?

Where in United States

Boston Children's HospitalBoston, United StatesContact: Belinda LennerzTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are:

Read full original descriptionShow less

* Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes control? * Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? * What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function?

Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months.

* Diabetes care devices will be connected for cloud-based data collection. * Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. * During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes. * Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life. * Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months.

Comparison will be made between a ketogenic vs standard diet.

The 2 groups in the trial

ketogenic dietTreatment being tested
The diet will be high in protein and healthy fats and comprise meat, fish, fibrous vegetables, nuts, dairy, and berries. Macronutrient composition will be \~ 5% carbohydrate, 20% protein, 70% fat. Participants will receive a daily multi-vitamin, magnesium supplement, and supplemental salt (bouillon cubes) to ascertain micronutrient sufficiency and help with transition to the diet.
Treatment: Ketogenic diet, food delivery and education
standard dietExisting treatment, for comparison
The diet will be consistent with prevailing dietary guidelines and recommendations and contain meat, fish, grains, vegetables, fruit and dairy. At least 50% of grain-based products will be whole grains. Meats will be primarily lean, and dairy products will be fat-free or low-fat. Macronutrient composition will be \~50% carbohydrate (\<10% added sugars), 20% protein, 30% fat. Participants will receive a daily multi-vitamin supplement to ascertain micronutrient sufficiency.
Treatment: Standard diet, food delivery and education