Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

Not Applicable

• Conditions: Insulin Sensitivity

• Registration Number: NCT02890108
• Lead Sponsor: Instituto de Nutrición y Tecnología de los Alimentos

Brief Summary

This study will compare the effect of acute consumption of two carbonated drinks, sweetened with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who normally consumed foods or drinks that contain non-caloric sweeteners

Detailed Description

During the last decades there has been a sustained increase in prevalence of overweight and obesity and, along with it, of chronic noncommunicable diseases. There have been addressed various management strategies, including sugar replacement for Non-caloric Artificial Sweeteners (NAS). Nevertheless, in several cohort studies it has found the opposite effect, it has observed associations between the consumption of NAS with greater weight gain and increased risk of type 2 diabetes and metabolic syndrome. In clinical trials, in both humans and mice, there has been greater association with glucose intolerance, being 3 possible mechanisms: 1) dysbiosis of the intestinal microbiota; 2) altered regulation of appetite cephalic phase and secretion of glucagon like peptide-1 (GLP-1); and 3) increased intestinal glucose absorption via increased Sodium-Glucose Linked Transporter-1 (SGLT-1) and Glucose transporter 2 (GLUT2), transporters to glucose absorption.

In the following review the major findings in the literature regarding the consumption of NAS and its deleterious effects on human health will be studied.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Primary Completion: 2016-09
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Body Mass Index (BMI) between 18,5 - 24,9 kg/mt2
• Healthy men or women
• Fasting plasma glucose < 100 mg/dL

Exclusion Criteria

• Consumption of drugs affecting glucose metabolism, antihypertensives or lipid lowering
• Subjects with insulin resistance, type 1 or 2 diabetes, dyslipidemia, hypertension; heart, liver or kidney disease, respiratory failure, stroke, or any chronic illness.
• Pregnant women.
• Being treated to gain or lose weight.
• History of recurrent episodes of acute diarrhea.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Insulin sensibility	Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.	One insulinemic curve will be conducted to assess the effect of consumption of artificially sweetened beverage on insulin response compared to the consumption of a sugar sweetened drink.

Secondary Outcome Measures

Name	Time	Method
Glycemic response	Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.	One glycemic curve will be conducted to assess the effect of consumption of artificially sweetened beverage on glycemic response compared to the consumption of a sugar sweetened drink.

Trial Locations

Locations (1)

Institute of Nutrition and Tecnology of Food, University of Chile; 🇨🇱 Santiago, Metropolitan region, Chile