Clinical trial NCT02890108: Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility
Official title: Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Sensitivity
Keywords: High-Intensity Sweeteners
Non-Nutritive Sweeteners
Artificial sweeteners
Glucose intolerance
Lead sponsor: Instituto de Nutrición y Tecnología de los Alimentos
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin sensibility
timeFrame: 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.
Secondary outcomes:
measure: Glycemic response
timeFrame: 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.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Institute of Nutrition and Tecnology of Food, University of Chile
state: Metropolitan region
Study officials:
affiliation: Institute of Nutrition and Tecnology of Food, University of Chile
name: Romina A Goza Ferreira, Magister c
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nutrition and Tecnology of Food, University of Chile
name: Sandra Hirsch Birn, Magister
role: STUDY_DIRECTOR
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