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Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes

NCT05872711 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Low carbohydrate diet

In order to maintain equal intensity of treatment, each patient will get a cooking workshop and received a personalized diet regime at baseline, based on the randomly assigned diet. Format and quality of the materials are similar. All diet plans are individualized and matched for energy intake personally . Participants will meet individually with the dietitian for diet instruction and support at week 1,2,4,7,10,12 and thereafter at 24 weeks for a total of seven frontal meetings. Twice during the first 12 weeks the dietician will conduct 10-15-minute motivational telephone calls with all the participants.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Orit Pinhas-Hamiel, MD · Head oh Pediatric Endocrinology Unit

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2024-10-31
Completion
2025-08-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872711 on ClinicalTrials.gov