Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes

Sheba Medical Center

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Other: Low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05872711

SHEBA-18-5537-OH-CTIL

Details and patient eligibility

About

The goal of this clinical trial is to compare the effect of low carbohydrate diet versus Mediterranean diet on blood sugar values in adolescents with type 1 diabetes.

The main question aims to answer whether a low carbohydrate diet is as effective as the Mediterranean diet for better glycaemic control in type 1 adolescents.

The investigators are also aiming to check whether low carbohydrate diet is safe and does not elevate cholesterol blood levels and whether the diet is adherable among youth with type 1 diabetes.

Participants with type 1 diabetes wearing a continuous glucose monitor and that will sign an informed consent will be randomly selected for 2 groups. One group will get the Mediterranean diet program and the other will get the low carbohydrate diet program, both for a duration of six months. Each participant will attend a cooking workshop at the beginning of the study. Blood work and stool samples will be taken at the beginning and 3 times through the study periodd. Each participant will attend meetings with the dietician thorough the period of the study.

Full description

Background and objective: Improved glycemic control of type 1 diabetes (T1DM), with low rates of adverse events was reported via an online community of children and adults who consume a of low carbohydrate diet (LCD). The investigators aim to compare the effects of a low carbohydrate diet (LCD) with those of a Mediterranean diet on glycemic control, lipid profile, bone metabolites and the microbiome profile in adolescents with type 1 diabetes.

Design A randomized, controlled trail. Families of adolescents in the Diabetes clinic in Edmond and Lily Safra Children's Hospital will be approached and offered to participate in a dietary intervention study. After participants will sign the informed consent, they will randomly be assigned into 2 diet treatment groups, the LCD (n=20) and the Mediterranean diet (n=20). Baseline nutrition teaching session and training and will be conducted for all participants and their parents. Participants will attend visit with the dietician at baseline, 2, 4, 8,12 weeks and will be given a 3-day food dairy to complete twice in that period. Measurements of weight, height, blood pressure, HbA1c, Time in range, number of hypoglycemia, lipid profile, creatinine, bone metabolites will be measured at baseline and 12 and 24 weeks and gut bacteria profile at baseline and at 24 weeks. Personality, quality of life, and socioeconomic questionnaires will be given to children and their parents.

Contribution of the suggested research:

In this research the investigators are aiming to show that LCD is as good as Mediterranean diet with improved glycemic control, safe, and adherable for adolescent with T1D.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• Connected to a continuous glucose monitoring (CGM)

Exclusion criteria

• History of eating disorder
• Family history of mental disorders

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Low carbohydrate diet

Experimental group

Description:

The LCD will provide 50-80g of carbohydrate per day with no caloric restriction. The planned macronutrient compositions (percentages of the total calories) of the diet were: 15-20% carbohydrate (\<80 g/day), 33% protein and 58% total fat.

Treatment:

Other: Low carbohydrate diet

Mediterranean diet

Active Comparator group

Description:

The MED group was prescribed a moderate-fat MED, rich in vegetables and low in red meat, with poultry and fish preferred to beef and lamb. The primary sources of added fat were 30 to 45 g of olive oil and a handful of nuts (five to seven nuts \<20g) per day. The planned macronutrient compositions of the diet were 40-50% carbohydrate, 25% protein and 35% total fat. The diet is based on the recommendations of Willett and Skerrett

Treatment:

Other: Low carbohydrate diet