Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05899166

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Ketogenic diet, food delivery and education

Standard diet, food delivery and education

Study Details

Brief summary:

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:

  • 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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT05899166

Start date

May 31, 2024

Status verified date

Apr, 2025

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ketogenic diet

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.

active comparator: standard diet

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.

Interventions

Ketogenic diet, food delivery and education

Meals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively.

Standard diet, food delivery and education

Meals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively.

Primary outcome measure

  • Decline in Beta-cell Function [ Time Frame: Change over 1, 5, and 9 months, corrected for baseline ]

Central Contacts and Locations

Central contacts

Belinda Lennerz, MD PhD

857-218-3896belinda.lennerz@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Keywords

  • carbohydrate reduced
  • low-carb
  • diabetes
  • keto

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-04-24.