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Clinical Trials/NCT02890108
NCT02890108UnknownNot Applicable

Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

Instituto de Nutrición y Tecnología de los Alimentos1 site in 1 country10 target enrollmentStarted: August 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Insulin sensibility

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Insulin sensibility

Time Frame: 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 Outcomes

  • 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.)

Investigators

Sponsor
Instituto de Nutrición y Tecnología de los Alimentos
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Romina Goza Ferreira

magister thesis student in adult clinical nutrition

Instituto de Nutrición y Tecnología de los Alimentos

Study Sites (1)

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