To Compare Influence of Breakfast With and Without Sweeteners on Postprandial Glycemic Response and Appetite-Satiety Sensation in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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. 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.
    

Intervention name(s): Test food breakfast with NCS or witout NCS
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant)
Primary purpose: Screening
Keywords: Type 1 diabetes; Non-Nutritive Sweeteners; High-Intensity Sweeteners; Sweetening Agents* / adverse effects; Male; Female; Adult; Stevia rebaudiana; Glycemic index; Sucralose; Breakfast