Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

Conditions
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Insulin Sensitivity

Intervention / Treatment
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* Dietary Supplement: Sugar sweetened beverages
* Dietary Supplement: Artificially sweetened beverages


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugar sweetened beverages<br>Subjects will receive, in 3 different ocassions, 350cc (1 can) of a sugar sweetened beverage, that contain 38,7 grams of carbs and 154 kcal, separated by at least 1 week each one | Dietary Supplement: Sugar sweetened beverages<br>* 350 cc (1 can) of sugar sweetened beverage<br>* Other names: Sugar sweetened drinks;|
| Experimental: Artificially sweetened beverage<br>Subjects will receive, in 3 different ocassions, 350cc (1 can) of a artificially sweetened beverage, that contain 84 mg of Aspartame, 56 mg of Acesulfame K and 0,7 kcal, separated by at least 1 week each one | Dietary Supplement: Artificially sweetened beverages<br>* 350 cc (1 can) of artificially sweetened beverage<br>* Other names: Artificially sweetened drinks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensibility | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic response | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-Intensity Sweeteners, Non-Nutritive Sweeteners, Artificial sweeteners, Glucose intolerance