Recruiting

Ketosis

Sponsor:

Boston Children's Hospital

Code:

NCT04219709

Conditions

Type1diabetes

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Very low carbohydrate diet

Standard carbohydrate diet

Study Details

Brief summary:

The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic \[very low carbohydrate\] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.

Conditions

Type1diabetes

Study ID

NCT04219709

Start date

Jan 3, 2020

Status verified date

Dec, 2024

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and females with T1D for at least 1 year
  • Age 18 to 40 years
  • Tanner stage ≥ IV
  • BMI 18.5-35 kg/m2
  • Stable glycemic control (HbA1c 6.5-9%)
  • Use of a continuous glucose monitor (CGM)
  • Use of an insulin pump
  • Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)

Exclusion Criteria:

  • Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
  • Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
  • Following a weight-loss or otherwise restrictive diet
  • Vigorous exercise >2 hours on >3 days a week
  • History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
  • Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
  • Significant psychiatric illness
  • Smoking, use of recreational drugs, or excessive alcohol consumption
  • Pregnancy or breastfeeding
  • Anemia
  • For participants who undergo MRI:

1. Standard MRI exclusion criteria
2. Irregular menses
3. Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data).

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Very low carbohydrate diet

Dietary Intervention, food delivery

active comparator: Standard diet

Dietary Intervention, food delivery

Interventions

Very low carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement with each meal as needed to promote digestive health, and a daily multi-vitamin, magnesium and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.

The diet composition will be as follows: 5% carbohydrate, 75% fat, 20% protein.

Standard carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.

The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein.

Primary outcome measure

  • Glycemic threshold for hypothalamic activation [ Time Frame: Diet week 5-12 ]

Central Contacts and Locations

Central contacts

Belinda Lennerz, MD PhD

+1 617 355 7476belinda.lennerz@childrens.harvard.edu

Locations

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 18, 2024

Last verified

Dec, 2024

Keywords

  • nutrition
  • very low carbohydrate diet
  • ketogenic diet
  • nutritional ketosis
  • cognitive function
  • brain
  • metabolism
  • ketones
  • ketosis

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 2024-12-18.