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Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes

ConditionsType 1 Diabetes (T1D)Nutrition TherapyGlycemic Control for Diabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital de Clinicas de Porto Alegre

About this trial

The goal of this clinical trial is to examine the effect of 3 versus 6 daily meals of isocaloric diets on glycemic control and variability in individuals with type 1 diabetes. Participants will be randomized in a crossover clinical trial and will receive two different types of isocaloric diet interventions, in 3 meals/day (calorie distribution: 30% at breakfast, 40% at lunch and 30% at dinner) or 6 meals/day (calorie distribution: 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 25% at dinner and 5% at evening snack), for three weeks, with a 4-week washout period between diets.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Adults (18 to 60 years old) with a medical diagnosis of type 1 diabetes mellitus

Individuals who perform carbohydrate counting

Individuals diagnosed > 12 months ago

Perform daily glycemic control using a blood glucose monitor or use of a glucose sensor

Disqualifiers

Individuals with glycated hemoglobin ≥ 11%

Individuals who are using NPH insulin

Retinopathy with vision deficit that limits the activities proposed in the disciplines.

Individuals with gastrointestinal disease such as celiac disease, Crohn's disease and Irritable Bowel Syndrome (IBS)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Three meals a day

    Behavioral

    This group will follow a dietary prescription consisting of three meals per day. The total energy value will be distributed in accordance with the macronutrient recommendations for type 1 diabetes (T1D), as follows: 45% of energy from total carbohydrates, prioritizing those with a low glycemic index; up to 30% from total fats, with unsaturated fats being the primary source; and 25% of energy from proteins. Caloric distribution will be divided into 30% for breakfast, 40% for lunch, and 30% for dinner, with 14 g of fiber per 1000 kcal distributed across the three meals. Furthermore, the gram amounts of the macronutrient in each meal will be apportioned such that 15-20% of the total carbohydrate intake, 7-10% of the total protein intake, and 10% of the total fat intake.Participants will also be instructed to maintain their habitual physical activity level.

  • Six meals a day

    Behavioral

    This group will follow a dietary prescription consisting of six meals per day. The total energy value will be distributed in accordance with the macronutrient recommendations for type 1 diabetes (T1D), as follows: 45% of energy from total carbohydrates, prioritizing those with a low glycemic index; up to 30% from total fats, with unsaturated fats being the primary source; and 25% of energy from proteins. Caloric distribution will be divided into 20% for breakfast, 10% morning snack, 30% for lunch, 10% afternoon snack, 25% for dinner and 5% bedtime snack, with 14 g of fiber per 1000 kcal distributed across the three meals. Furthermore, the gram amounts of the macronutrient in each meal will be apportioned such that 5-10% of the total carbohydrate intake, 2-7% of the total protein intake, and 2-8% of the total fat intake.Participants will also be instructed to maintain their habitual physical activity level.

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: 3 meals a dayExperimental treatment 1 intervention
Group B: 6 meals a dayActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in glycemic control

Differences Between Groups in Glycemic Control and Variability Using HbA1c and Freestyle Libre Continuous Glucose Monitoring (CGM)

Time frame
Baseline, 5, 6, 12 and 13 weeks

Secondary outcomes

1

Change in Glycated Hemoglobin

Difference between groups in glycated hemoglobin

Time frame
Baseline, 3, 6, 10 and 13 weeks
2

Glycemic Variability

For continuous glucose monitoring and assessment of glycemic variability, the FreeStyle Libre, ABBOTT® device will be used. FreeStyle Libre consists of a continuous glucose monitoring (SMCG) system. Glycemic variability will be assessed using time on target parameters of values between 70 and 180 mg/dL, values between 70 and 140mg/dL, time in hypoglycemia and time above target and coefficient of variability as measures of glycemic variability

Time frame
5 and 12 weeks
3

Changes in body composition

Weight, fat-free mass and fat mass will be assessed by Bioelectrical Impedance (body composition analyzer tetrapolar InBody 370S, BiospaceCo. Ltd, Seoul, South Korea). Anthropometric measures include brachial, neck, waist, hip and calf circumferences, with participants wearing light clothing and barefoot.

Time frame
Baseline, 3, 6, 10 and 13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Source ClinicalTrials.gov

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