Type 1 Diabetes (T1D)NCT06934707
Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes
A study testing Three meals a day and Six meals a day in people with Type 1 Diabetes (T1D) and Nutrition Therapy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Nutrition Therapy, Glycemic Control for Diabetes Mellitus
- What is being tested?
- Three meals a day and Six meals a day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2025to 29 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
- Women who are pregnant, intending to become pregnant during the study period, or who are breastfeeding.
- Hyperglycemia characterized by acute symptoms: polyuria, polydipsia, and/or weight loss in the last 3 months. ● Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma.
- Night workers who work after 10 pm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre
Fernando Gerchman, +55 51 33598127, fgerchman@hcpa.edu.br
About this study
Official title: Meal Frequency, Glycemic Control and Variability in Individuals With Type 1 Diabetes: a Randomized Crossover Clinical 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.
Read the detailed description
This is a single center, randomized, open-label, non-inferiority and crossover clinical trial. Subjects with type 1 diabetes (T1D) and will be recruited through advertisement on the web page of Hospital de Clínicas de Porto Alegre (HCPA), type 1 diabetes outpatient clinic of HCPA, local newspaper, television and social media, or referred by a doctor or nutritionist, from external to HCPA services. After screening and selection according to inclusion criteria, participants will undergo a clinical, laboratory and nutritional evaluation following a standard assessment protocol. After all baseline assessments, they will be randomly allocated to one of the following interventions for 3 weeks and after a washout period, they will be in the other intervention. While glycemic control (A1c and Glycated albumin) and variability (6 points daily capillary blood glucose tests) are assessed during the baseline period, the first week of each intervention, and the last week of washout and continuous interstitial glucose measurements that are performed in the last 14 days of each intervention. Blinding is maintained outcome assesment.
- Being tested
- Three meals a day, Six meals a day
- Keywords
- type 1 Diabetes, glycemic control, diet, meal frequency
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three meals a dayBehavioural
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 dayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 meals a day | Experimental | Diet for maintaining body weight with three meals per day Receives: Behavioral: Three meals a day |
| 6 meals a day | Active comparator | Diet for maintaining body weight with six meals a day Receives: Behavioral: Six meals a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control
Differences Between Groups in Glycemic Control and Variability Using HbA1c and Freestyle Libre Continuous Glucose Monitoring (CGM)
Measured: Baseline, 5, 6, 12 and 13 weeks
Secondary outcomes (3)
Change in Glycated Hemoglobin
Difference between groups in glycated hemoglobin
Measured: Baseline, 3, 6, 10 and 13 weeks
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
Measured: 5 and 12 weeks
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.
Measured: Baseline, 3, 6, 10 and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each intervention phase will span 3 weeks, followed by a 4-week washout phase.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Gerchman, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934707
- Sponsor's protocol ID
- 2022-0583
- Other IDs
- 2022-0583
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal Frequency, Glycemic Control and Variability in Individuals With Type 1 Diabetes: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT06934707
- Acronym / sponsor ID
- 2022-0583
- Keywords
- type 1 Diabetes, glycemic control, diet, meal frequency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, randomized, open-label, non-inferiority and crossover clinical trial. Subjects with type 1 diabetes (T1D) and will be recruited through advertisement on the web page of Hospital de Clínicas de Porto Alegre (HCPA), type 1 diabetes outpatient clinic of HCPA, local newspaper, television and social media, or referred by a doctor or nutritionist, from external to HCPA services. After screening and selection according to inclusion criteria, participants will undergo a clinical, laboratory and nutritional evaluation following a standard assessment protocol. After all baseline assessments, they will be randomly allocated to one of the following interventions for 3 weeks and after a washout period, they will be in the other intervention. While glycemic control (A1c and Glycated albumin) and variability (6 points daily capillary blood glucose tests) are assessed during the baseline period, the first week of each intervention, and the last week of washout and continuous interstitial glucose measurements that are performed in the last 14 days of each intervention. Blinding is maintained outcome assesment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Each intervention phase will span 3 weeks, followed by a 4-week washout phase.
| Arm | Type | Receives |
|---|---|---|
| 3 meals a day | Experimental | Behavioral: Three meals a dayDiet for maintaining body weight with three meals per day |
| 6 meals a day | Active comparator | Behavioral: Six meals a dayDiet for maintaining body weight with six meals a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Adults (18 to 60 years old) with a medical diagnosis of type 1 diabetes mellitus
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three meals a dayThis 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. | Behavioural | 3 meals a day |
| Six meals a dayThis 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. | Behavioural | 6 meals a day |
Primary outcome
Change in glycemic control
Time frame: Baseline, 5, 6, 12 and 13 weeks
Differences Between Groups in Glycemic Control and Variability Using HbA1c and Freestyle Libre Continuous Glucose Monitoring (CGM)
3 secondary outcomes
Change in Glycated Hemoglobin
Time frame: Baseline, 3, 6, 10 and 13 weeks
Glycemic Variability
Time frame: 5 and 12 weeks
Changes in body composition
Time frame: Baseline, 3, 6, 10 and 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Gerchman principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three meals a day and Six meals a day in people with Type 1 Diabetes (T1D) and Nutrition Therapy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Gerchman (+55 51 33598127, fgerchman@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control (time frame: Baseline, 5, 6, 12 and 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.