Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes

NCT06934707 | Not Yet Recruiting

• 1 other identifier: 2022-0583
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes (T1D); Nutrition Therapy; Glycemic Control for Diabetes Mellitus

Keywords

type 1 Diabetes; glycemic control; diet; meal frequency

Outcome Measures

Primary Outcomes (1)

• Change in glycemic control

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

  Baseline, 5, 6, 12 and 13 weeks

Secondary Outcomes (3)

• Change in Glycated Hemoglobin

  Baseline, 3, 6, 10 and 13 weeks

• Glycemic Variability

  5 and 12 weeks

• Changes in body composition

  Baseline, 3, 6, 10 and 13 weeks

Study Arms (2)

3 meals a day

EXPERIMENTAL

Diet for maintaining body weight with three meals per day

Behavioral: Three meals a day

6 meals a day

ACTIVE COMPARATOR

Diet for maintaining body weight with six meals a day

Behavioral: Six meals a day

Interventions

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.

3 meals a day

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.

6 meals a day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have the ability to understand and be able to adhere to the proposed interventions.
• Complete a detailed 3-day food record for one week prior to the intervention and record episodes of hypoglycemia (\<70 mg/dL) and hyperglycemia (\>180 mg/dL)
• Able and willing to provide written informed consent and comply with the requirements of the study protocol.

You may not qualify if:

• 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)
• History of bariatric surgery
• That you are following a carbohydrate, protein and/or fat restriction diet
• Individuals with BMI ≥ 40kg/m2
• Chronic kidney disease with estimated glomerular filtration \<30mL/min per 1.73 m2.
• Liver failure or chronic viral hepatitis
• Active or progressive neurodegenerative disease
• Use of medications that affect glucose metabolism (corticosteroids and immunosuppressants) or cause weight loss. ● Treatment with weight-reducing agents (e.g., orlistat, sibutramine, topiramate, liraglutide) in the last 12 weeks prior to screening.
• Treatment with thyroid hormone that has not been maintained at a stable dose in the last 12 weeks prior to screening.
• History of active substance abuse (including alcohol) in the last year.
• Serious psychiatric illness: Mood disorders, anxiety disorders, severe psychotic disorders, and personality disorders that are revealed or identified in the clinical evaluation, listed or reported in the medical record, and that have no clinical findings.
• Predisposition to or diagnosis of eating disorders.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Fernando Gerchman

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Gerchman

CONTACT

+55 51 33598127; fgerchman@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants and the care providers will not be blinded. People involved in assessing outcomes and with data analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each intervention phase will span 3 weeks, followed by a 4-week washout phase.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 18, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)