Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes

NCT05872711 | Unknown DMC

• 1 other identifier: SHEBA-18-5537-OH-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Type 1 Diabetes

Keywords

Adolescents; Glycemic targets; Low carbohydrate diet; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Change of time in range (TIR) 70-180 mg/dl after following a LCD or a MD in adolescents with T1DM.

  Time spent in range (TIR) 70-180 mg/dl assessed by CGM was downloaded at each visit with the dietician. Severe hypoglycemia was defined as an episode requiring assistance and was confirmed by documentation of a blood glucose value less than 54 mg per deciliter

  The change of TIR between baseline and after six months

Secondary Outcomes (7)

• Evaluation of the influence of LCD vs. MD on HbA1c.

  The change between baseline and after six months

• Assessment of the impact of dietary changes after an LCD vs. MD on gut dysbiosis

  The change between baseline and after six months

• Assessment of the impact of both diets on bone turnover measures.

  The change of bone turnover at baseline and after six months

• Assessment of the impact of dietary changes after an LCD vs. MD on quality of life.

  The change between baseline and after six months in the quality of life.

• Change in BMI after LCD vs. MD

  BMI change at baseline and after six months

Study Arms (2)

Low carbohydrate diet

EXPERIMENTAL

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.

Other: Low carbohydrate diet

Mediterranean diet

ACTIVE COMPARATOR

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

Other: Low carbohydrate diet

Interventions

Low carbohydrate diet OTHER

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.

Low carbohydrate diet; Mediterranean diet

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of eating disorder
• Family history of mental disorders

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba_Medical_Center

Ramat Gan, 52621, Israel

RECRUITING

Related Publications (2)

• Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.

  PMID: 29735574 RESULT

• Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21.

  PMID: 30924570 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Orit Pinhas-Hamiel, MD

  Head oh Pediatric Endocrinology Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orit Pinhas-Hamiel, MD

CONTACT

+97235305015; Orit.hamiel@sheba.health.gov.il

Neriya Levran, Msc

CONTACT

+972545432176; neriyale@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Endocrinology Department in Sheba Medical Center

Model Details: The study design is a randomized, parallel assignment clinical trial without blinding (open label) due to the impracticality of blinding diets

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 24, 2023
• Study Start: April 19, 2023
• Primary Completion: October 31, 2024
• Study Completion: August 1, 2025
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)