Diabetes Mellitus, Type 1T1DNCT06201806
To Compare Influence of Breakfast With and Without Sweeteners on Postprandial Glycemic Response and Appetite-Satiety Sensation in Subjects With Type 1 Diabetes
A study testing Test food breakfast with NCS or witout NCS in people with Diabetes Mellitus, Type 1, run by University of Chile at 1 site in Chile.
Trial summary
Introduction: Type 1 diabetes is a chronic autoimmune disease with multifactorial etiology, resulting in partial or complete destruction of pancreatic β cells, leading to an absolute deficit of insulin and vital dependence on exogenous insulin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Test food breakfast with NCS or witout NCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- 2 Jan 2019to 20 Dec 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with type 1 diabetes (DM1) aged between 18 and 60 years.
- Confirmed diagnosis of DM1.
- Users of an intensified regimen with insulin analogs (multiple doses) or users of an insulin pump.
Who cannot join
- History of celiac disease.
- Allergy and/or food intolerances to any of the test foods.
- Subjects who carry out moderate to intense physical activity three or more times a week for more than 30 minutes at a time
- Subjects with the use of vitamin supplements or antioxidants
- Subjects with an allergy or aversion to the sweeteners used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Consumption of a Breakfast With and Without Sweeteners (Stevia and Sucralose) on Postprandial Glycemic Response and Appetite-Satiety Sensation in Subjects With Type 1 Diabetes: A Controlled Clinical Trial.
Introduction: Type 1 diabetes is a chronic autoimmune disease with multifactorial etiology, resulting in partial or complete destruction of pancreatic β cells, leading to an absolute deficit of insulin and vital dependence on exogenous insulin. Treatment for type 1 diabetes (T1D) involves externally replacing the functions of pancreatic β cells through the administration of external insulin, aiming to achieve blood glucose levels close to normal ranges. Among the factors influencing postprandial glycemic excursions is the glycemic index (GI), defined as the potential of a food's carbohydrates to raise blood glucose. Many studies to date conclude that foods with a higher glycemic index (GI) result in a greater area under the curve in postprandial glycemia.
Studies in children and adults with diabetes have reported that individuals with higher non-nutritive sweetener (NNS) consumption do not exceed the acceptable daily intake (ADI) limit in most cases. Regarding the effect of non-caloric sweetener consumption on appetite-satiety and postprandial glycemia in T1D patients, there is no available evidence.
Read more
General Objective: To compare the effect of consuming a breakfast with and without sweeteners on postprandial glycemic response and appetite-satiety sensation in subjects with type 1 diabetes.
Methodology: A prospective experimental study will be conducted with non-probabilistic convenience sampling over 2 months. Thirty-two adult volunteers with T1D using intensified insulin analog schemes or insulin pumps will be recruited. Nutritional assessment and a dietary survey will be conducted to determine the habitual consumption of non-nutritive sweeteners. Two breakfasts will be tested, one with and one without non-nutritive sweeteners (separated by 7 days). Additionally, a test with White Bread (as a standard food) will be conducted. Both the standard food and the breakfast will provide 50 g of available carbohydrates in each session. Subjects will administer rapid-acting insulin before ingestion according to their ratio and sensitivity. The glycemic index of each breakfast will be determined, and the glycemic response will be analyzed using capillary glucometry and continuous glucose monitoring, with each subject serving as their own control. Finally, appetite-satiety will be determined using a visual analog scale. One-way ANOVA and the t-student test will be used for statistical analysis. Statistical analysis will be performed using IBM SPSS Statistics v.22 (SPSS Inc., Chicago, Illinois). A p-value < 0.05 will be considered significant for each analysis.
Expected Results: It is expected that the breakfast with non-nutritive sweeteners will induce a higher postprandial glycemic response, measured as a greater area under the curve in adult T1D subjects. Furthermore, it is anticipated that after consuming the breakfast with non-nutritive sweeteners, T1D subjects will experience increased appetite and reduced satiety.
Read the detailed description
Experimental Design: The protocol to be used follows the procedure recommended by FAO/WHO 2008. On the day before the test, subjects will be instructed to maintain a similar intake to their usual diet, with a preferably light dinner; intense physical activity and alcohol consumption will also be restricted. Each subject will attend with a minimum fasting period of 10 hours. The foods used in the breakfast tests are specified in Table 2, and both breakfasts provide 50g of available carbohydrates (CHO).
Glycemic Responses (GR): Blood samples will be obtained through capillary blood sampling using the Accu-Chek® Instant glucometer. Two fasting blood samples will be taken, and the average result of these values will be considered as the baseline blood glucose concentration. Immediately after this, subjects will be given the test breakfast or white bread as appropriate within a time frame of 12 to 15 minutes. After 12 or 15 minutes, capillary blood samples will be taken at 30, 45, 60, 90, 120, 150, and 180 minutes after ingestion. In addition, continuous glucose monitoring with a sensor will be performed.
Calculation of the Glycemic Index (GI): The area under the curve (AUC) will be geometrically calculated for each food using the trapezoid rule, excluding the area under the baseline. To obtain the GI of the test breakfasts, the AUC of the breakfast with or without sweeteners consumed by each subject will be expressed as a percentage of the AUC increase of the standard food consumed by the same subject. The final GI value of the test breakfast with or without sweeteners will be the average of the GIs obtained in each group.
Appetite Determination: The 10 cm Visual Analog Scale (VAS) with words anchored at each end expressing the most positive and negative ratings will be used. It will be used to evaluate the sensations of hunger, satiety, and fullness, defined as follows: Hunger: "Vital and indispensable physiological need to nourish our body," Satiety: "Feeling of satisfaction, referring to satisfying the physiological need to nourish our organism," and Fullness: "State that invites stopping eating." Additionally, desire to consume food, desire for something sweet, salty, tasty, or fatty will be assessed. The person will mark their sensation on the scale, and the distance from the left end to the marked point will be measured, allowing quantification of the sensation.
Statistical Analysis: Results will be expressed as mean ± standard deviation. One-way ANOVA will be used to compare glycemic responses and the GI value between groups. Additionally, t-student will be used to compare glycemic responses between breakfasts. Statistical analysis will be performed using the IBM SPSS Statistics v.22 statistical program (SPSS Inc., Chicago, Illinois). A p-value < 0.05 will be considered significant for each analysis.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Test food breakfast with NCS or witout NCS
- Keywords
- Type 1 diabetes, Non-Nutritive Sweeteners, High-Intensity Sweeteners, Sweetening Agents* / adverse effects, Male, Female, Adult, Stevia rebaudiana, Glycemic index, Sucralose, Breakfast
- 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.
Test food breakfast with NCS or witout NCSOther
Study Intervention: 30 drops (70.8 mg) of a stevia and sucralose mix were chosen based on Ford et al. 2011, indicating a 48 mg sucralose concentration comparable to the sweetness of a standard diet soda, due to a lack of studies on the acute effects of combined non-nutritive sweeteners.
Glycemic Responses (GR): Blood samples collected using Accu-Chek® Instant glucometer, with fasting samples establishing baseline glucose concentration. Test breakfast or white bread consumed within 12 to 15 minutes, followed by capillary blood sampling at various intervals. Continuous glucose monitoring with a sensor was also implemented.
Glycemic Index (GI) Calculation: Geometric calculation of the area under the curve (AUC) for each food, excluding the baseline area. Test breakfast GI determined by expressing AUC as a percentage of the standard food AUC. Final GI value averaged across groups.
| Study group | Role | What they receive |
|---|---|---|
| Test food breakfast with NCS | Experimental | Experimental: Participants with type 1 diabetes will consume Breakfast I with a mixed sweetener of stevia and sucralose, equivalent to 30 drops (36 mg stevia + 34.8 mg sucralose). Total non-nutritive sweeteners (NNS) amount to 70.8 mg.
Intervention: Breakfast I includes whole wheat pita bread (43 g), turkey ham (40 g), gouda cheese (18 g), semi-skimmed milk 200 cc (enhanced with 15 drops of sweetener), and natural orange juice 200 cc (with an additional 15 drops of sweetener). 15 drops for each preparation, making a total of 30 drops, providing 50 grams of available carbohydrates. Subjects administer rapid-acting insulin before breakfast based on their ratio and sensitivity. Receives: Other: Test food breakfast with NCS or witout NCS |
| Test food breakfast without NCS | Experimental | Experimental: Intervention involves the consumption of a breakfast without non-nutritive sweeteners (NNS).
Intervention: Subjects with type 1 diabetes who ingest Breakfast II (without sweetener): Whole wheat pita bread (43 g), turkey ham (40 g), gouda cheese (18 g), semi-skimmed milk 200 cc, and natural orange juice 200 cc.
Intervention includes the ingestion of 50 grams of available carbohydrates in the breakfast without NNS. Subjects will administer rapid-acting insulin before breakfast based on their ratio and sensitivity. Receives: Other: Test food breakfast with NCS or witout NCS |
| Reference food | Active comparator | Intervention involves the consumption of White Bread (standard food): 86g of crustless white sandwich bread as the standard food to reach the 50g of available CHO. Subjects administer rapid-acting insulin before consumption based on their ratio and sensitivity. Receives: Other: Test food breakfast with NCS or witout NCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Responses (GR)
Blood samples were collected through capillary blood sampling using the Accu-Chek® Instant glucometer. Two fasting blood samples were taken, and the average result of these values was considered as the baseline blood glucose concentration. Subsequently, participants were provided with the test breakfast or white bread, as appropriate, within a time frame of 12 to 15 minutes. After this period, capillary blood samples were collected at 30, 45, 60, 90, 120, 150, and 180 minutes post-ingestion. Additionally, continuous glucose monitoring with a sensor was conducted.
Measured: time frame of 12 to 15 minutes. After this period, capillary blood samples were collected at 30, 45, 60, 90, 120, 150, and 180 minutes post-ingestion.
Secondary outcomes (3)
Determination of Nutritional Status:
Each participant was asked to wear light clothing and remove their shoes. Subsequently, body weight was measured using a scale with an accuracy of 0.1 kg. Height was measured in centimeters (cm) using a stadiometer with an accuracy of 0.1 cm. Nutritional status was classified according to the World Health Organization (WHO) 2000 report.
Measured: Once time in the beggining of the study
Determination of Sweetener Intake (Modified Consumption Trend Survey):
A retrospective survey was administered, prompting participants to recall their dietary habits over a one-month period. The survey gathered information on specific food consumption patterns, emphasizing the frequency of intake of items containing added sweeteners and discretionary sweetener consumption. This assessment also aimed to identify participants categorized as high or low consumers of non-nutritive sweeteners (NNS).
Measured: Once time in the beggining of the study
Assessment of Appetite:
The 10 cm Visual Analog Scale (VAS) with anchored words at each end was employed. This scale expresses the most positive and negative ratings. It was utilized to evaluate the sensations of hunger, satiety, and fullness, defined as follows: Hunger: "Vital and indispensable physiological need to nourish our body," Satiety: "Feeling of satisfaction, related to fulfilling the physiological need to nourish our body," and Fullness: "State that encourages stopping eating." Additionally, desires for consuming specific foods, such as something sweet, salty, tasty, or fatty, were included. Participants marked their sensations on the scale, and the distance from the left end to the marked point was measured, allowing for the quantification of the sensation.
Measured: It is measured at the beginning of the intervention, as well as at 60 and 120 minutes after the start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start2 Jan 2019
- Primary completion15 Mar 2020
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study follows FAO/WHO 2008 protocol for glycemic index in breakfasts with and without non-nutritive sweeteners. Participants prep with a similar diet, light dinner, and a 10-hour fast before the test. The experimental design, implemented three times independently for 7-14 days, employs a crossover approach with each DM1 individual serving as their own control. Interventions feature test breakfasts with or without sweeteners, providing 50g of CHO. A third intervention uses white bread as a standard for glycemic response. This design calculates the area under the curve, contrasts experimental and standard responses, and determines the glycemic index for both test breakfasts.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Chilena de Diabetes y Endocrinología (SOCHED)
- Responsible party
- Principal investigator, Verónica Sambra Vásquez, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201806
- Sponsor's protocol ID
- Proyecto Soched N°2019-04
- Acronym
- T1D
- Status last verified
- Jan 2024
- First submitted
- 31 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of a Breakfast With and Without Sweeteners (Stevia and Sucralose) on Postprandial Glycemic Response and Appetite-Satiety Sensation in Subjects With Type 1 Diabetes: A Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06201806
- Acronym / sponsor ID
- T1D / Proyecto Soched N°2019-04
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes, Non-Nutritive Sweeteners, High-Intensity Sweeteners, Sweetening Agents* / adverse effects, Male, Female, Adult, Stevia rebaudiana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Sociedad Chilena de Diabetes y Endocrinología (SOCHED)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 11 Jan 2024 (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.
Introduction: Type 1 diabetes is a chronic autoimmune disease with multifactorial etiology, resulting in partial or complete destruction of pancreatic β cells, leading to an absolute deficit of insulin and vital dependence on exogenous insulin. Treatment for type 1 diabetes (T1D) involves externally replacing the functions of pancreatic β cells through the administration of external insulin, aiming to achieve blood glucose levels close to normal ranges. Among the factors influencing postprandial glycemic excursions is the glycemic index (GI), defined as the potential of a food's carbohydrates to raise blood glucose. Many studies to date conclude that foods with a higher glycemic index (GI) result in a greater area under the curve in postprandial glycemia.
Studies in children and adults with diabetes have reported that individuals with higher non-nutritive sweetener (NNS) consumption do not exceed the acceptable daily intake (ADI) limit in most cases. Regarding the effect of non-caloric sweetener consumption on appetite-satiety and postprandial glycemia in T1D patients, there is no available evidence.
General Objective: To compare the effect of consuming a breakfast with and without sweeteners on postprandial glycemic response and appetite-satiety sensation in subjects with type 1 diabetes.
Methodology: A prospective experimental study will be conducted with non-probabilistic convenience sampling over 2 months. Thirty-two adult volunteers with T1D using intensified insulin analog schemes or insulin pumps will be recruited. Nutritional assessment and a dietary survey will be conducted to determine the habitual consumption of non-nutritive sweeteners. Two breakfasts will be tested, one with and one without non-nutritive sweeteners (separated by 7 days). Additionally, a test with White Bread (as a standard food) will be conducted. Both the standard food and the breakfast will provide 50 g of available carbohydrates in each session. Subjects will administer rapid-acting insulin before ingestion according to their ratio and sensitivity. The glycemic index of each breakfast will be determined, and the glycemic response will be analyzed using capillary glucometry and continuous glucose monitoring, with each subject serving as their own control. Finally, appetite-satiety will be determined using a visual analog scale. One-way ANOVA and the t-student test will be used for statistical analysis. Statistical analysis will be performed using IBM SPSS Statistics v.22 (SPSS Inc., Chicago, Illinois). A p-value < 0.05 will be considered significant for each analysis.
Expected Results: It is expected that the breakfast with non-nutritive sweeteners will induce a higher postprandial glycemic response, measured as a greater area under the curve in adult T1D subjects. Furthermore, it is anticipated that after consuming the breakfast with non-nutritive sweeteners, T1D subjects will experience increased appetite and reduced satiety.
Detailed description
Experimental Design: The protocol to be used follows the procedure recommended by FAO/WHO 2008. On the day before the test, subjects will be instructed to maintain a similar intake to their usual diet, with a preferably light dinner; intense physical activity and alcohol consumption will also be restricted. Each subject will attend with a minimum fasting period of 10 hours. The foods used in the breakfast tests are specified in Table 2, and both breakfasts provide 50g of available carbohydrates (CHO).
Glycemic Responses (GR): Blood samples will be obtained through capillary blood sampling using the Accu-Chek® Instant glucometer. Two fasting blood samples will be taken, and the average result of these values will be considered as the baseline blood glucose concentration. Immediately after this, subjects will be given the test breakfast or white bread as appropriate within a time frame of 12 to 15 minutes. After 12 or 15 minutes, capillary blood samples will be taken at 30, 45, 60, 90, 120, 150, and 180 minutes after ingestion. In addition, continuous glucose monitoring with a sensor will be performed.
Calculation of the Glycemic Index (GI): The area under the curve (AUC) will be geometrically calculated for each food using the trapezoid rule, excluding the area under the baseline. To obtain the GI of the test breakfasts, the AUC of the breakfast with or without sweeteners consumed by each subject will be expressed as a percentage of the AUC increase of the standard food consumed by the same subject. The final GI value of the test breakfast with or without sweeteners will be the average of the GIs obtained in each group.
Appetite Determination: The 10 cm Visual Analog Scale (VAS) with words anchored at each end expressing the most positive and negative ratings will be used. It will be used to evaluate the sensations of hunger, satiety, and fullness, defined as follows: Hunger: "Vital and indispensable physiological need to nourish our body," Satiety: "Feeling of satisfaction, referring to satisfying the physiological need to nourish our organism," and Fullness: "State that invites stopping eating." Additionally, desire to consume food, desire for something sweet, salty, tasty, or fatty will be assessed. The person will mark their sensation on the scale, and the distance from the left end to the marked point will be measured, allowing quantification of the sensation.
Statistical Analysis: Results will be expressed as mean ± standard deviation. One-way ANOVA will be used to compare glycemic responses and the GI value between groups. Additionally, t-student will be used to compare glycemic responses between breakfasts. Statistical analysis will be performed using the IBM SPSS Statistics v.22 statistical program (SPSS Inc., Chicago, Illinois). A p-value < 0.05 will be considered significant for each analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study follows FAO/WHO 2008 protocol for glycemic index in breakfasts with and without non-nutritive sweeteners. Participants prep with a similar diet, light dinner, and a 10-hour fast before the test. The experimental design, implemented three times independently for 7-14 days, employs a crossover approach with each DM1 individual serving as their own control. Interventions feature test breakfasts with or without sweeteners, providing 50g of CHO. A third intervention uses white bread as a standard for glycemic response. This design calculates the area under the curve, contrasts experimental and standard responses, and determines the glycemic index for both test breakfasts.
| Arm | Type | Receives |
|---|---|---|
| Test food breakfast with NCS | Experimental | Other: Test food breakfast with NCS or witout NCSExperimental: Participants with type 1 diabetes will consume Breakfast I with a mixed sweetener of stevia and sucralose, equivalent to 30 drops (36 mg stevia + 34.8 mg sucralose). Total non-nutritive sweeteners (NNS) amount to 70.8 mg. Intervention: Breakfast I includes whole wheat pita bread (43 g), turkey ham (40 g), gouda cheese (18 g), semi-skimmed milk 200 cc (enhanced with 15 drops of sweetener), and natural orange juice 200 cc (with an additional 15 drops of sweetener). 15 drops for each preparation, making a total of 30 drops, providing 50 grams of available carbohydrates. Subjects administer rapid-acting insulin before breakfast based on their ratio and sensitivity. |
| Test food breakfast without NCS | Experimental | Other: Test food breakfast with NCS or witout NCSExperimental: Intervention involves the consumption of a breakfast without non-nutritive sweeteners (NNS). Intervention: Subjects with type 1 diabetes who ingest Breakfast II (without sweetener): Whole wheat pita bread (43 g), turkey ham (40 g), gouda cheese (18 g), semi-skimmed milk 200 cc, and natural orange juice 200 cc. Intervention includes the ingestion of 50 grams of available carbohydrates in the breakfast without NNS. Subjects will administer rapid-acting insulin before breakfast based on their ratio and sensitivity. |
| Reference food | Active comparator | Other: Test food breakfast with NCS or witout NCSIntervention involves the consumption of White Bread (standard food): 86g of crustless white sandwich bread as the standard food to reach the 50g of available CHO. Subjects administer rapid-acting insulin before consumption based on their ratio and sensitivity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults with type 1 diabetes (DM1) aged between 18 and 60 years.
- Confirmed diagnosis of DM1.
- Users of an intensified regimen with insulin analogs (multiple doses) or users of an insulin pump.
Key exclusion criteria (5 listed)
- History of celiac disease.
- Allergy and/or food intolerances to any of the test foods.
- Subjects who carry out moderate to intense physical activity three or more times a week for more than 30 minutes at a time
- Subjects with the use of vitamin supplements or antioxidants
- Subjects with an allergy or aversion to the sweeteners used in the study
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 |
|---|---|---|
| Test food breakfast with NCS or witout NCSStudy Intervention: 30 drops (70.8 mg) of a stevia and sucralose mix were chosen based on Ford et al. 2011, indicating a 48 mg sucralose concentration comparable to the sweetness of a standard diet soda, due to a lack of studies on the acute effects of combined non-nutritive sweeteners. Glycemic Responses (GR): Blood samples collected using Accu-Chek® Instant glucometer, with fasting samples establishing baseline glucose concentration. Test breakfast or white bread consumed within 12 to 15 minutes, followed by capillary blood sampling at various intervals. Continuous glucose monitoring with a sensor was also implemented. Glycemic Index (GI) Calculation: Geometric calculation of the area under the curve (AUC) for each food, excluding the baseline area. Test breakfast GI determined by expressing AUC as a percentage of the standard food AUC. Final GI value averaged across groups. | Other | Reference food, Test food breakfast with NCS, Test food breakfast without NCS |
Primary outcome
Glycemic Responses (GR)
Time frame: time frame of 12 to 15 minutes. After this period, capillary blood samples were collected at 30, 45, 60, 90, 120, 150, and 180 minutes post-ingestion.
Blood samples were collected through capillary blood sampling using the Accu-Chek® Instant glucometer. Two fasting blood samples were taken, and the average result of these values was considered as the baseline blood glucose concentration. Subsequently, participants were provided with the test breakfast or white bread, as appropriate, within a time frame of 12 to 15 minutes. After this period, capillary blood samples were collected at 30, 45, 60, 90, 120, 150, and 180 minutes post-ingestion. Additionally, continuous glucose monitoring with a sensor was conducted.
3 secondary outcomes
Determination of Nutritional Status:
Time frame: Once time in the beggining of the study
Determination of Sweetener Intake (Modified Consumption Trend Survey):
Time frame: Once time in the beggining of the study
Assessment of Appetite:
Time frame: It is measured at the beginning of the intervention, as well as at 60 and 120 minutes after the start.
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 16 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test food breakfast with NCS or witout NCS in people with Diabetes Mellitus, Type 1, run by University of Chile at 1 site in Chile.
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 3 inclusion and 5 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 16 Jan 2024. 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 Chile. 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?
Glycemic Responses (GR) (time frame: time frame of 12 to 15 minutes. After this period, capillary blood samples were collected at 30, 45, 60, 90, 120, 150, and 180 minutes post-ingestion.). 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 16 Jan 2024.