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

NCT ID: NCT05654285

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-08
• Study Completion Date: 2016-05-27

Brief Summary

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.

Conditions

Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Carbonated water

355ml of an orally ingested carbonated water

Group Type: PLACEBO_COMPARATOR

Cola beverage with aspartame and acesulfame K

Intervention Type: OTHER

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.

Cola beverage with sucrose and stevia

Intervention Type: OTHER

Cola beverage with aspartame and acesulfame K

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

Group Type: EXPERIMENTAL

Cola beverage with aspartame and acesulfame K

Intervention Type: OTHER

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.

Cola beverage with sucrose and stevia

Intervention Type: 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)

Group Type: EXPERIMENTAL

Cola beverage with aspartame and acesulfame K

Intervention Type: OTHER

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.

Cola beverage with sucrose and stevia

Intervention Type: OTHER

Cola beverage with sucrose

355ml of an orally ingested carbonated cola drink, sweetened with 37g of sucrose

Group Type: ACTIVE_COMPARATOR

Cola beverage with aspartame and acesulfame K

Intervention Type: OTHER

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.

Cola beverage with sucrose and stevia

Intervention Type: OTHER

Interventions

Cola beverage with aspartame and acesulfame K

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.

Intervention Type: OTHER

Cola beverage with sucrose and stevia

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role: lead

Responsible Party

Cesar Galicia Ayala

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

America L Miranda-Lora, PhD

Role: STUDY_DIRECTOR

Epidemiological research unit of Endocrinology and nutrition, HIMFG

Miguel Klünder-Klünder, PhD

Role: STUDY_CHAIR

Deputy director of research management, HIMFG

Cesar Galicia-Ayala, Master

Role: PRINCIPAL_INVESTIGATOR

Nursing research unit, HIMFG

Armando Vilchis-Ordoñez, PhD

Role: STUDY_CHAIR

Clinical lab, HIMFG

Briceida López-Martínez, PhD

Role: STUDY_CHAIR

Clinical lab, HIMFG

Other Identifiers

HIM/2016/015 SSA 1221

Identifier Type: -

Identifier Source: org_study_id