To Compare Influence of Breakfast With and Without Sweeteners on Postprandial Glycemic Response and Appetite-Satiety Sensation in Subjects With Type 1 Diabetes

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

OTHER

Test food breakfast with NCS or witout NCS

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.

Sponsors & Collaborators

• Sociedad Chilena de Diabetes y Endocrinología (SOCHED)

  collaborator UNKNOWN

• University of Chile

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-02

Primary Completion

2020-03-15

Completion

2022-12-20

Countries

• Chile

Study Locations