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Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

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ClinicalTrials.gov Identifier: NCT02890108
Recruitment Status : Unknown
Verified August 2016 by Romina Goza Ferreira, Instituto de Nutrición y Tecnología de los Alimentos.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Romina Goza Ferreira, 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

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Dietary Supplement: Sugar sweetened beverages Dietary Supplement: Artificially sweetened beverages Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility
Study Start Date : August 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Sugar sweetened beverages
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
350 cc (1 can) of sugar sweetened beverage
Other Name: Sugar sweetened drinks

Experimental: Artificially sweetened beverage
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
350 cc (1 can) of artificially sweetened beverage
Other Name: Artificially sweetened drinks




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Glycemic response [ 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 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.



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890108


Contacts
Contact: Romina A Goza Ferreira, Magister c +56950088329 rominagoza@gmail.com
Contact: Sandra Hirsch Birn, Magister +56229781495 ext +56229781499 shirsch@inta.uchile.cl

Locations
Chile
Institute of Nutrition and Tecnology of Food, University of Chile Recruiting
Santiago, Metropolitan region, Chile
Contact: Verónica Cornejo Espinoza, Director    +56229781 410    vcornejo@inta.uchile.cl   
Contact: Sandra Hirsch Birn, Academic    +56229781495 ext +56229781499    shirsch@inta.uchile.cl   
Principal Investigator: Romina A Goza Ferreira, Magister c         
Principal Investigator: Sandra Hirsch Birn, Magister         
Sub-Investigator: Gladys Barrera Acevedo, Magister         
Sponsors and Collaborators
Instituto de Nutrición y Tecnología de los Alimentos
Investigators
Principal Investigator: Romina A Goza Ferreira, Magister c Institute of Nutrition and Tecnology of Food, University of Chile
Study Director: Sandra Hirsch Birn, Magister Institute of Nutrition and Tecnology of Food, University of Chile

Publications:

Responsible Party: Romina Goza Ferreira, magister thesis student in adult clinical nutrition, Instituto de Nutrición y Tecnología de los Alimentos
ClinicalTrials.gov Identifier: NCT02890108     History of Changes
Other Study ID Numbers: EANC-1
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All the data is confidential and only will be show if ethics committee ask for it

Keywords provided by Romina Goza Ferreira, Instituto de Nutrición y Tecnología de los Alimentos:
High-Intensity Sweeteners
Non-Nutritive Sweeteners
Artificial sweeteners
Glucose intolerance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases