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

NCT05654285 | Completed DMC

• 1 other identifier: HIM/2016/015 SSA 1221
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Measurements were made at 120 minutes after the intake of the drink

Study Arms (4)

Carbonated water

PLACEBO COMPARATOR

355ml of an orally ingested carbonated water

Other: Cola beverage with aspartame and acesulfame K; Other: Cola beverage with sucrose and stevia

Cola beverage with aspartame and acesulfame K

EXPERIMENTAL

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

Cola beverage with sucrose and stevia

EXPERIMENTAL

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

Cola beverage with sucrose

ACTIVE COMPARATOR

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

Interventions

Cola beverage with aspartame and acesulfame K 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.

Carbonated water; Cola beverage with aspartame and acesulfame K; Cola beverage with sucrose; Cola beverage with sucrose and stevia

Cola beverage with sucrose and stevia OTHER

Carbonated water; Cola beverage with aspartame and acesulfame K; Cola beverage with sucrose; Cola beverage with sucrose and stevia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary participation expressed through the signing of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome

Interventions

Aspartame; acetosulfame; Sucrose; stevioside

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• America L Miranda-Lora, PhD

  Epidemiological research unit of Endocrinology and nutrition, HIMFG

  STUDY DIRECTOR

• Miguel Klünder-Klünder, PhD

  Deputy director of research management, HIMFG

  STUDY CHAIR

• Cesar Galicia-Ayala, Master

  Nursing research unit, HIMFG

  PRINCIPAL INVESTIGATOR

• Armando Vilchis-Ordoñez, PhD

  Clinical lab, HIMFG

  STUDY CHAIR

• Briceida López-Martínez, PhD

  Clinical lab, HIMFG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple masking was applied, as described below. Participants: The drinks were offered in standardized disposable cups so that the participants could not visually identify the test drink. All beverages were offered at approximately 4°C and participants were asked to consume them within 10 minutes. Investigator: All participants received the mineral water (control) in the first study session. Allocation to the remaining 3 interventions was randomized for each participant, and members of the research team who administered the beverages, performed blood sampling, processed samples in the laboratory, or followed participants during the study sessions were unaware of the allocation, that is, the type of drink that was administered to each participant. Outcomes Assessor: The investigator who performed the statistical analysis did not have access to the identity of the participants or the allocation of interventions.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 16, 2022
• Study Start: February 8, 2016
• Primary Completion: May 27, 2016
• Study Completion: May 27, 2016
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share