Enteroendocrine Hormonal Response After the Ingestion of Cola Beverages With Sucrose and Non-nutritive Sweeteners

Hospital Infantil de Mexico Federico Gomez

Status

Completed

Conditions

Obesity

Diabetes Mellitus, Type 2

Metabolic Syndrome

Treatments

Other: Cola beverage with aspartame and acesulfame K

Other: Cola beverage with sucrose and stevia

Study type

Interventional

Funder types

Other

Identifiers

NCT05654285

HIM/2016/015 SSA 1221

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Voluntary participation expressed through the signing of informed consent

Exclusion criteria

Pregnancy (date of last menstruation >28 days)
History of diabetes mellitus or glucose intolerance, endocrinopathies, or pancreatic diseases
Treatment with medications or supplements that modify glucose and insulin (eg antihypertensives, corticosteroids, hypoglycemic agents, hormonal agents, etc.)
Gastrointestinal diseases or conditions that alter gastric emptying and intestinal transit
Hypersensitivity to the compounds that will be used in the study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 4 patient groups, including a placebo group

Carbonated water

Placebo Comparator group

Description:

355ml of an orally ingested carbonated water

Treatment:

Other: Cola beverage with aspartame and acesulfame K

Other: Cola beverage with sucrose and stevia

Cola beverage with aspartame and acesulfame K

Experimental group

Description:

355ml of an orally ingested carbonated cola drink, sweetened with 142mg of aspartame and acesulfame k, combined (soft drink in its commercial presentation)

Treatment:

Other: Cola beverage with aspartame and acesulfame K

Other: Cola beverage with sucrose and stevia

Cola beverage with sucrose and stevia

Experimental group

Description:

355ml of an orally ingested carbonated cola drink, sweetened with 16g of sucrose and 15.62mg of stevia (soft drink in its commercial presentation)

Treatment:

Other: Cola beverage with aspartame and acesulfame K

Other: Cola beverage with sucrose and stevia

Cola beverage with sucrose

Active Comparator group