Diabetes Mellitus Type 2NCT04127994
Glycemic Variability Comparing Two vs Five Meals in Type 2 Diabetes
A study testing Comparing 3 versus 5 meals in type 2 diabetes patients in people with Diabetes Mellitus Type 2 and Overweight and Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
The frequency of meals is a very important aspect of nutrition, with profound effects on human health and in life expectancy. Excessive energy consumption is totally associated with a significant increase in the incidence of chronic diseases including diabetes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Overweight and Obesity, Meal Time
- What is being tested?
- Comparing 3 versus 5 meals in type 2 diabetes patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 17 Aug 2018to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oral hypoglycemic agents
- HbA1c <9%
- Less than 10 years of evolution
- Diabetes Mellitus type 2
- Overweight or obese
- Age 40-70 years
- BMI ≥25 to < 40 kg/m
Who cannot join
- Obesity 3rd grade
- DM 1
- Hospitalization in the last 3 months
- >10 years of evolution
- HbA1c >9%
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''
Mexico City, Mexico City, 14080
About this study
Official title: Effect on Glycemic Variability, Weight and Oxidative Stress Markers FGF 21 in a Low Calorie Diet of Three Meals Compared With a Conventional Low Calorie Plan of Five Meals in Patients With Type 2 Diabetes With Overweight or Obesity
The frequency of meals is a very important aspect of nutrition, with profound effects on human health and in life expectancy. Excessive energy consumption is totally associated with a significant increase in the incidence of chronic diseases including diabetes. That is why nutritional therapy is recommended for all people with diabetes mellitus type 1 and 2 as an effective complement to your medical treatment. For overweight or obese type 2 diabetic patients, a low-calorie diet along with healthy eating patterns are recommended for weight loss. Similarly, modest body weight decrease may provide clinical benefits in patients, such as improved blood glucose, blood pressure, lipid profile, and others. Data about the role of nutritional habits and energy density being important precursors of obesity and diabetes are well known. On the other hand, data regarding frequency and timing of meals and how these factors relate to corporal weight are not totally understood.
Read the detailed description
In general, hypocaloric plans for patients with type 2 diabetes mellitus are consumed in five or six small meals per day. Eating more often is presumed to reduce hunger and thus energy consumption. However, the effects of meal frequency on human health and longevity are unclear.
Therefore, this study will be carried out in which the differences in the impact of nutritional therapy between a hypocaloric conventional 5 times meal versus a 3-meal low-calorie plan will be demonstrated.
The procedures will be as follows:
50 patients with DM2 from the Institute's Diabetes Clinic who are overweight or obese and between 40 and 70 years of age and who are found to have oral hypoglycemic agents, HbA1c less than 9% and less than 10 years old will be recruited of evolution.
Clinical evaluation:
A complete medical history and physical examination will be performed in order to confirm the presence of the inclusion criteria and rule out the presence of exclusion criteria. An anthropometric and body composition assessment (waist and hip circumference, height, weight and percentage of fat) as well as blood pressure measurement will be made. A history of coronary heart disease, menopausal status and use of hormone therapy, smoking, alcohol consumption and physical activity (through a questionnaire of physical activity validated in the Mexican population) will be conducted.
Nutritional assessment:
Patients will be divided into 2 groups without any distinction.
The first group of 25 patients will undergo a caloric restriction with a caloric restriction of 15% of their usual daily intake with a 40% macronutrient distribution in Carbohydrates, 20% Protein and 40% Lipids in three times of (TC5) over a period of 12 weeks in which the following variables will be measured: (Weight, Glucose Variability: Monitor, HbA1c, blood glucose, Lipid Profile, Oxidative stress, FGF-21, Blood Pressure and Hunger-Satiety Levels.)
At the first visit, the clinical evaluation will be elaborated, which consists of a complete physical examination in which vital signs will be measured, neck and head examination, examination of the thorax and abdomen, exploration of upper and lower extremities. As well as a complete nutritional assessment that includes; Assessment of body composition using bioimpedance with body composition analyzer jawon iOi 353, Reminder of food consumption of 72hrs to collect information on the diet of each patient. Based on the information collected will proceed to prescribe the individualized TC5 plan and will be given a 24/7 reminder format to be filled by the patient for a week, in addition to giving the indication to perform home glucose measurement once a day In random scheme.
To evaluate attachment to the nutritional plan, the patient will be cited 15 days later to perform daily consumption assessment using the 24/7 reminder format filled out by the patient and a 72hrs reminder performed through an interview. Likewise, levels of Hunger-Satiety will be measured with the tables of the institute Joslin validated for Mexican population.
If the patient adheres to the diet, blood samples will be taken for the measurement of the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) and after that place the Medtronic model Ipro2 continuous glucose monitor with In order to monitor the patient's blood glucose for 7 days.
At the end of the 7 days, the patient will be asked to remove the sensor and re-evaluate dietary attachment.
The TC5 plan will be continued for 6 weeks, and at the end of this period the patient will be recalled to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) Blood pressure and levels of Hunger-Satiety.
The TC5 regimen will be continued for a further 6 weeks. At the end of the period the patient will be asked to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21), Weight, Blood Pressure and Hunger-Satiety levels.
The second group of 25 patients will undergo a caloric restriction with a caloric restriction of 15% of their usual daily intake, with a 40% macronutrient distribution in Carbohydrates, 20% Protein and 40% Lipids in three times of (TC3) over a period of 12 weeks in which the following variables (Weight, Glucose Variability: Monitor, HbA1c, blood glucose, Lipid Profile, Oxidative, FGF-21, Blood Pressure and Hunger-Satiety levels are measured.) At the first visit, the clinical evaluation will be elaborated, which consists of a complete physical examination in which vital signs will be measured, neck and head examination, examination of the thorax and abdomen, exploration of upper and lower extremities. As well as a complete nutritional evaluation that includes, assessment of body composition using bioimpedance with jawon iOi 353 body composition analyzer, food consumption reminder of 72hrs to collect information on each patient's diet. Based on the information collected will proceed to prescribe the individualized TC3 plan and will be given a 24/7 reminder format to be filled by the patient for a week, in addition to giving the indication to perform home glucose measurement once a day in random scheme.
To evaluate attachment to the nutritional plan, the patient will be cited 15 days later to perform daily consumption assessment using the 24/7 reminder format filled out by the patient and a 72hrs reminder performed through an interview. Likewise, levels of Hunger-Satiety will be measured with the tables of the institute Joslin validated for Mexican population.
If the patient adheres to the diet, blood samples will be taken for the measurement of the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) and after that place the Medtronic model Ipro2 continuous glucose monitor with in order to monitor the patient's blood glucose for 7 days.
At the end of the 7 days, the patient will be asked to remove the sensor and re-evaluate dietary attachment.
The TC3 plan will be continued for 6 weeks, and at the end of this period the patient will be recalled to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) Blood pressure and levels of Hunger-Satiety. The TC3 regimen will be continued for a further 6 weeks. At the end of the period the patient will be asked to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21), Weight, Blood Pressure and Hunger-Satiety levels.
- Conditions
- Diabetes Mellitus Type 2, Overweight and Obesity, Meal Time
- Being tested
- Comparing 3 versus 5 meals in type 2 diabetes patients
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing 3 versus 5 meals in type 2 diabetes patientsOther
We will compare a 3 meals regimen versus a 5 meal regimen in patients with type 2 diabetes and overweight or obesity, to analyze which of the regimens have better outcomes in glycemic variability
| Study group | Role | What they receive |
|---|---|---|
| 3 meals | Experimental | Patients with type 2 diabetes will be submitted to a 3 meal regimen for 3 months.
We will compare their basal complete blood chemistry, somatometric measurements versus the same variables after 3 months. Receives: Other: Comparing 3 versus 5 meals in type 2 diabetes patients |
| 5 meals | Experimental | Patients with type 2 diabetes will be submitted to a 5 meal regimen for 3 months.
We will compare their basal complete blood chemistry, somatometric measurements versus the same variables after 3 months. Receives: Other: Comparing 3 versus 5 meals in type 2 diabetes patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of 3 stroke diet in glycemic variability compared to a 5 stroke diet
Patients from both groups (3 stroke and 5 stroke diet) will be monitored for 7 days using intensive capillar blood glucose measurements 4 times per day (Fasting, 2 hours post breakfast, 2 hours post meal and 2 hours post dinner). The basal intensive blood glucose meaasurement monitoring will start at week 1 (first visit), and will end at day 7 and final intensive blood glucose meaasurement monitoring will start at week 11 and will end 7 days after (final visit) comparing glycemic variability between them. Mean difference of glycaemic variability (MAGE) calculated in mmol/L.
Measured: 12 weeks
Secondary outcomes (8)
Impact of 3 stroke diet in glycosylated hemoglobin levels compared to a 5 stroke diet
Mean difference of glycosylated hemoglobin represented in %
Measured: 12 weeks
Impact of 3 stroke diet in fasting glucose levels compared to a 5 stroke diet
Mean difference of fasting glucose represented in mg/dL
Measured: 12 weeks
Impact of 3 stroke diet in triglycerides levels compared to a 5 stroke diet
Mean difference of triglycerides represented in mg/dL
Measured: 12 weeks
Impact of 3 stroke diet in cholesterol levels compared to a 5 stroke diet
Mean difference of cholesterol levels represented in mg/dL
Measured: 12 weeks
Impact of 3 stroke diet in fibroblast growth factor 21 levels compared to a 5 stroke diet
Mean difference of fibroblast growth factor 21 levels represented in pg/ml.
Measured: 12 weeks
Impact of 3 stroke diet in systolic and diastolic blood pressure compared to a 5 stroke diet
Mean difference of systolic and diastolic blood pressure represented in mmHg
Measured: 12 weeks
Impact of 3 stroke diet in satiety compared to a 5 stroke diet
The mean difference in satiety will be estimated using the Queensland University's hunger-satiety questionnaire, which consists of a score ranging from 1 to 10, where 1 represents the highest level of hunger and 10 represents the highest level of satiety.
Measured: 12 weeks
Impact of 3 stroke diet in weight loss compared to a 5 stroke diet
Mean difference of weight represented in kilograms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start17 Aug 2018
- Primary completion11 Dec 2023
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Ángel Gómez Sámano, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Miguel Angel Gómez Sámano, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127994
- Sponsor's protocol ID
- 2100
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Glycemic Variability, Weight and Oxidative Stress Markers FGF 21 in a Low Calorie Diet of Three Meals Compared With a Conventional Low Calorie Plan of Five Meals in Patients With Type 2 Diabetes With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04127994
- Acronym / sponsor ID
- 2100
- Conditions
- Diabetes Mellitus Type 2, Overweight and Obesity, Meal Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 16 Oct 2019 (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 frequency of meals is a very important aspect of nutrition, with profound effects on human health and in life expectancy. Excessive energy consumption is totally associated with a significant increase in the incidence of chronic diseases including diabetes. That is why nutritional therapy is recommended for all people with diabetes mellitus type 1 and 2 as an effective complement to your medical treatment. For overweight or obese type 2 diabetic patients, a low-calorie diet along with healthy eating patterns are recommended for weight loss. Similarly, modest body weight decrease may provide clinical benefits in patients, such as improved blood glucose, blood pressure, lipid profile, and others. Data about the role of nutritional habits and energy density being important precursors of obesity and diabetes are well known. On the other hand, data regarding frequency and timing of meals and how these factors relate to corporal weight are not totally understood.
Detailed description
In general, hypocaloric plans for patients with type 2 diabetes mellitus are consumed in five or six small meals per day. Eating more often is presumed to reduce hunger and thus energy consumption. However, the effects of meal frequency on human health and longevity are unclear.
Therefore, this study will be carried out in which the differences in the impact of nutritional therapy between a hypocaloric conventional 5 times meal versus a 3-meal low-calorie plan will be demonstrated.
The procedures will be as follows:
50 patients with DM2 from the Institute's Diabetes Clinic who are overweight or obese and between 40 and 70 years of age and who are found to have oral hypoglycemic agents, HbA1c less than 9% and less than 10 years old will be recruited of evolution.
Clinical evaluation:
A complete medical history and physical examination will be performed in order to confirm the presence of the inclusion criteria and rule out the presence of exclusion criteria. An anthropometric and body composition assessment (waist and hip circumference, height, weight and percentage of fat) as well as blood pressure measurement will be made. A history of coronary heart disease, menopausal status and use of hormone therapy, smoking, alcohol consumption and physical activity (through a questionnaire of physical activity validated in the Mexican population) will be conducted.
Nutritional assessment:
Patients will be divided into 2 groups without any distinction.
The first group of 25 patients will undergo a caloric restriction with a caloric restriction of 15% of their usual daily intake with a 40% macronutrient distribution in Carbohydrates, 20% Protein and 40% Lipids in three times of (TC5) over a period of 12 weeks in which the following variables will be measured: (Weight, Glucose Variability: Monitor, HbA1c, blood glucose, Lipid Profile, Oxidative stress, FGF-21, Blood Pressure and Hunger-Satiety Levels.)
At the first visit, the clinical evaluation will be elaborated, which consists of a complete physical examination in which vital signs will be measured, neck and head examination, examination of the thorax and abdomen, exploration of upper and lower extremities. As well as a complete nutritional assessment that includes; Assessment of body composition using bioimpedance with body composition analyzer jawon iOi 353, Reminder of food consumption of 72hrs to collect information on the diet of each patient. Based on the information collected will proceed to prescribe the individualized TC5 plan and will be given a 24/7 reminder format to be filled by the patient for a week, in addition to giving the indication to perform home glucose measurement once a day In random scheme.
To evaluate attachment to the nutritional plan, the patient will be cited 15 days later to perform daily consumption assessment using the 24/7 reminder format filled out by the patient and a 72hrs reminder performed through an interview. Likewise, levels of Hunger-Satiety will be measured with the tables of the institute Joslin validated for Mexican population.
If the patient adheres to the diet, blood samples will be taken for the measurement of the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) and after that place the Medtronic model Ipro2 continuous glucose monitor with In order to monitor the patient's blood glucose for 7 days.
At the end of the 7 days, the patient will be asked to remove the sensor and re-evaluate dietary attachment.
The TC5 plan will be continued for 6 weeks, and at the end of this period the patient will be recalled to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) Blood pressure and levels of Hunger-Satiety.
The TC5 regimen will be continued for a further 6 weeks. At the end of the period the patient will be asked to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21), Weight, Blood Pressure and Hunger-Satiety levels.
The second group of 25 patients will undergo a caloric restriction with a caloric restriction of 15% of their usual daily intake, with a 40% macronutrient distribution in Carbohydrates, 20% Protein and 40% Lipids in three times of (TC3) over a period of 12 weeks in which the following variables (Weight, Glucose Variability: Monitor, HbA1c, blood glucose, Lipid Profile, Oxidative, FGF-21, Blood Pressure and Hunger-Satiety levels are measured.) At the first visit, the clinical evaluation will be elaborated, which consists of a complete physical examination in which vital signs will be measured, neck and head examination, examination of the thorax and abdomen, exploration of upper and lower extremities. As well as a complete nutritional evaluation that includes, assessment of body composition using bioimpedance with jawon iOi 353 body composition analyzer, food consumption reminder of 72hrs to collect information on each patient's diet. Based on the information collected will proceed to prescribe the individualized TC3 plan and will be given a 24/7 reminder format to be filled by the patient for a week, in addition to giving the indication to perform home glucose measurement once a day in random scheme.
To evaluate attachment to the nutritional plan, the patient will be cited 15 days later to perform daily consumption assessment using the 24/7 reminder format filled out by the patient and a 72hrs reminder performed through an interview. Likewise, levels of Hunger-Satiety will be measured with the tables of the institute Joslin validated for Mexican population.
If the patient adheres to the diet, blood samples will be taken for the measurement of the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) and after that place the Medtronic model Ipro2 continuous glucose monitor with in order to monitor the patient's blood glucose for 7 days.
At the end of the 7 days, the patient will be asked to remove the sensor and re-evaluate dietary attachment.
The TC3 plan will be continued for 6 weeks, and at the end of this period the patient will be recalled to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) Blood pressure and levels of Hunger-Satiety. The TC3 regimen will be continued for a further 6 weeks. At the end of the period the patient will be asked to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21), Weight, Blood Pressure and Hunger-Satiety levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 meals | Experimental | Other: Comparing 3 versus 5 meals in type 2 diabetes patientsPatients with type 2 diabetes will be submitted to a 3 meal regimen for 3 months. We will compare their basal complete blood chemistry, somatometric measurements versus the same variables after 3 months. |
| 5 meals | Experimental | Other: Comparing 3 versus 5 meals in type 2 diabetes patientsPatients with type 2 diabetes will be submitted to a 5 meal regimen for 3 months. We will compare their basal complete blood chemistry, somatometric measurements versus the same variables after 3 months. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Oral hypoglycemic agents
- HbA1c <9%
- Less than 10 years of evolution
- Diabetes Mellitus type 2
- Overweight or obese
Key exclusion criteria (6 listed)
- Obesity 3rd grade
- DM 1
- Hospitalization in the last 3 months
- >10 years of evolution
- HbA1c >9%
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 |
|---|---|---|
| Comparing 3 versus 5 meals in type 2 diabetes patientsWe will compare a 3 meals regimen versus a 5 meal regimen in patients with type 2 diabetes and overweight or obesity, to analyze which of the regimens have better outcomes in glycemic variability | Other | 3 meals, 5 meals |
Primary outcome
Impact of 3 stroke diet in glycemic variability compared to a 5 stroke diet
Time frame: 12 weeks
Patients from both groups (3 stroke and 5 stroke diet) will be monitored for 7 days using intensive capillar blood glucose measurements 4 times per day (Fasting, 2 hours post breakfast, 2 hours post meal and 2 hours post dinner). The basal intensive blood glucose meaasurement monitoring will start at week 1 (first visit), and will end at day 7 and final intensive blood glucose meaasurement monitoring will start at week 11 and will end 7 days after (final visit) comparing glycemic variability between them. Mean difference of glycaemic variability (MAGE) calculated in mmol/L.
8 secondary outcomes
Impact of 3 stroke diet in glycosylated hemoglobin levels compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in fasting glucose levels compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in triglycerides levels compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in cholesterol levels compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in fibroblast growth factor 21 levels compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in systolic and diastolic blood pressure compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in satiety compared to a 5 stroke diet
Time frame: 12 weeks
Impact of 3 stroke diet in weight loss compared to a 5 stroke diet
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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. This study is not recruiting at the moment.
Miguel Angel Gómez Sámano, MD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparing 3 versus 5 meals in type 2 diabetes patients in people with Diabetes Mellitus Type 2 and Overweight and Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 6 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: finished, as of the sponsor's last update on 27 Mar 2026. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of 3 stroke diet in glycemic variability compared to a 5 stroke diet (time frame: 12 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 27 Mar 2026.