An interventional study of Cola beverage with aspartame and acesulfame K and Cola beverage with sucrose and stevia in Obesity, Diabetes Mellitus, Type 2 and Metabolic Syndrome, sponsored by Hospital Infantil de Mexico Federico Gomez. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Not applicable, Interventional, and Prevention
Introduction: The consumption of non-nutritive sweeteners (NNS) has been increasing in recent years, as an alternative to replace sugars and reduce the additional intake of carbohydrates, with the idea of reducing the risk of developing obesity, metabolic syndrome, and diabetes. However, recent evidence shows that their chronic intake induces endocrine alterations that may have an important contribution to the increase in body weight. Few studies have explored the acute effects of NNS beverage consumption on endocrine response, and to date, the evidence has been inconsistent regarding post-drinking effects and potential health risks.
Objective: To evaluate the effect of 3 different types of cola beverages, compared with carbonated water, on glucose, insulin, glucagon, and appetite-regulating hormones during the first 120 minutes after ingestion.
Methods: A triple-blind, randomized crossover controlled trial was carried out in which 20 healthy adult individuals (10 men and 10 women) were included. With a washout period of one week (7 days) and fasting for 8 hours, each participant consumed orally 355 mL of carbonated water (CAR), and the 3 different cola beverages sweetened with sucrose (SUC), aspartame/acesulfame K (ASP), and sucrose/stevia (STE), in its commercial presentation. The serum levels of glucose, insulin, glucagon, GLP-1, GIP, PYY, leptin, pancreatic polypeptide, and ghrelin were determined during the administration of each one of the drinks before the intake of the drink and later at 30, 60, 90, and 120 minutes.
Statistical analysis: A descriptive analysis of the variables was performed. The global response of glucose, insulin and appetite-regulating hormones was estimated and the Area Under the Curve (AUC) was obtained using a trapezoidal model and analyzed for each outcome by one-factor ANOVA. An ANOVA for repeated measures was performed considering treatment and time as factors, and comparisons were made with the carbonated water as a control using the Bonferroni test. P values less than 0.05 were considered statistically significant.
Ethical considerations: Our institution's Research, Bioethics, and Biosafety committees authorized the project. All the participants were informed about the objective, the procedures, and the possible adverse effects considered within the study, and they signed the informed consent before the start of the interventions.
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Exclusion Criteria:
355ml of an orally ingested carbonated water
Other: Cola beverage with aspartame and acesulfame K · Other: Cola beverage with sucrose and stevia
355ml of an orally ingested carbonated cola drink, sweetened with 142mg of aspartame and acesulfame k, combined (soft drink in its commercial presentation)
Other: Cola beverage with aspartame and acesulfame K · Other: Cola beverage with sucrose and stevia
355ml of an orally ingested carbonated cola drink, sweetened with 16g of sucrose and 15.62mg of stevia (soft drink in its commercial presentation)
Other: Cola beverage with aspartame and acesulfame K · Other: Cola beverage with sucrose and stevia
355ml of an orally ingested carbonated cola drink, sweetened with 37g of sucrose
Other: Cola beverage with aspartame and acesulfame K · Other: Cola beverage with sucrose and stevia
Before starting the study: Subjects were asked to avoid non-nutritive sweetener consumption for 48 hours prior to the study sessions. A standardized menu of 346 Kcal was prescribed for dinner and fasting for at least 8 hours prior to each study session. A 7-day washout period was left between each study session. Session 1: Weight, height, and waist circumference were measured, the BMI was calculated, and sociodemographic data of the participants and information on the habitual consumption of soft drinks were collected. In each session: The beverages were offered at approximately 4°C, in standardized disposable cups, and the participants were asked to drink them in a maximum time of 10 minutes. Heart rate, respiratory rate, and blood pressure were measured before the intervention and every 30 minutes during the observation period. The subjects who manifested adverse sensations were referred to receive medical attention and withdrawn from the session.
Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), leptin, and ghrelin
4-5mL of venous blood was obtained from each participant and immediately transferred to the laboratory for analysis. The glucose oxidase technique was implemented to determine serum glucose levels. This technique has high intra- and inter-assay precision (CV: 2.1 and 1.73%, respectively), and high correlation with Gernon's reagent (r=0.993). For the determination of insulin, glucagon, GLP-1, PYY, GIP, PP, leptin, and ghrelin levels, implemented the Milliplex Map® immunological assay, which has an intra-assay coefficient of variation of less than 10% and an inter-assay coefficient of less than 15%, with an accuracy greater than 97%. The tests were carried out in duplicate.
Time frame: Measurements were made at 0 minute (before the intake of the drink)
Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), leptin, and ghrelin
4-5mL of venous blood was obtained from each participant and immediately transferred to the laboratory for analysis. The glucose oxidase technique was implemented to determine serum glucose levels. This technique has high intra- and inter-assay precision (CV: 2.1 and 1.73%, respectively), and high correlation with Gernon's reagent (r=0.993). For the determination of insulin, glucagon, GLP-1, PYY, GIP, PP, leptin, and ghrelin levels, implemented the Milliplex Map® immunological assay, which has an intra-assay coefficient of variation of less than 10% and an inter-assay coefficient of less than 15%, with an accuracy greater than 97%. The tests were carried out in duplicate.
Time frame: Measurements were made at 30 minutes after the intake of the drink
Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), leptin, and ghrelin
4-5mL of venous blood was obtained from each participant and immediately transferred to the laboratory for analysis. The glucose oxidase technique was implemented to determine serum glucose levels. This technique has high intra- and inter-assay precision (CV: 2.1 and 1.73%, respectively), and high correlation with Gernon's reagent (r=0.993). For the determination of insulin, glucagon, GLP-1, PYY, GIP, PP, leptin, and ghrelin levels, implemented the Milliplex Map® immunological assay, which has an intra-assay coefficient of variation of less than 10% and an inter-assay coefficient of less than 15%, with an accuracy greater than 97%. The tests were carried out in duplicate.
Time frame: Measurements were made at 60 minutes after the intake of the drink
Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), leptin, and ghrelin
4-5mL of venous blood was obtained from each participant and immediately transferred to the laboratory for analysis. The glucose oxidase technique was implemented to determine serum glucose levels. This technique has high intra- and inter-assay precision (CV: 2.1 and 1.73%, respectively), and high correlation with Gernon's reagent (r=0.993). For the determination of insulin, glucagon, GLP-1, PYY, GIP, PP, leptin, and ghrelin levels, implemented the Milliplex Map® immunological assay, which has an intra-assay coefficient of variation of less than 10% and an inter-assay coefficient of less than 15%, with an accuracy greater than 97%. The tests were carried out in duplicate.
Time frame: Measurements were made at 90 minutes after the intake of the drink
Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), leptin, and ghrelin
4-5mL of venous blood was obtained from each participant and immediately transferred to the laboratory for analysis. The glucose oxidase technique was implemented to determine serum glucose levels. This technique has high intra- and inter-assay precision (CV: 2.1 and 1.73%, respectively), and high correlation with Gernon's reagent (r=0.993). For the determination of insulin, glucagon, GLP-1, PYY, GIP, PP, leptin, and ghrelin levels, implemented the Milliplex Map® immunological assay, which has an intra-assay coefficient of variation of less than 10% and an inter-assay coefficient of less than 15%, with an accuracy greater than 97%. The tests were carried out in duplicate.
Time frame: Measurements were made at 120 minutes after the intake of the drink
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Hospital Infantil de Mexico Federico Gomez