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

NCT06201806 | Completed DMC

• 1 other identifier: Proyecto Soched N°2019-04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Type 1 diabetes; Non-Nutritive Sweeteners; High-Intensity Sweeteners; Sweetening Agents* / adverse effects; Male; Female; Adult; Stevia rebaudiana; Glycemic index; Sucralose; Breakfast

Outcome Measures

Primary Outcomes (1)

• 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.

  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:

  Once time in the beggining of the study

• Determination of Sweetener Intake (Modified Consumption Trend Survey):

  Once time in the beggining of the study

• Assessment of Appetite:

  It is measured at the beginning of the intervention, as well as at 60 and 120 minutes after the start.

Study Arms (3)

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.

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.

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.

Other: Test food breakfast with NCS or witout NCS

Interventions

Test food breakfast with NCS or witout NCS OTHER

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.

Reference food; Test food breakfast with NCS; Test food breakfast without NCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Sociedad Chilena de Diabetes y Endocrinología (SOCHED): collaborator

Study Sites (1)

University of Chile. Faculty of Medicine

Santiago, 7500908, Chile

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Zinostatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Enediynes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Diynes; Polyynes; Alkynes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant is unaware of the assigned breakfast intervention, but they were aware of consuming white bread as the standard.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: January 2, 2019
• Primary Completion: March 15, 2020
• Study Completion: December 20, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CL (1)