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Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

Primary Purpose

Insulin Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Sugar sweetened beverages
Artificially sweetened beverages
Sponsored by
Instituto de Nutrición y Tecnología de los Alimentos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Sensitivity focused on measuring High-Intensity Sweeteners, Non-Nutritive Sweeteners, Artificial sweeteners, Glucose intolerance

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute of Nutrition and Tecnology of Food, University of ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sugar sweetened beverages

Artificially sweetened beverage

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2016
Last Updated
August 31, 2016
Sponsor
Instituto de Nutrición y Tecnología de los Alimentos
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1. Study Identification

Unique Protocol Identification Number
NCT02890108
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Nutrición y Tecnología de los Alimentos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
Keywords
High-Intensity Sweeteners, Non-Nutritive Sweeteners, Artificial sweeteners, Glucose intolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sugar sweetened beverages
Arm Type
Experimental
Arm Description
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
Arm Title
Artificially sweetened beverage
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar sweetened beverages
Other Intervention Name(s)
Sugar sweetened drinks
Intervention Description
350 cc (1 can) of sugar sweetened beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Artificially sweetened beverages
Other Intervention Name(s)
Artificially sweetened drinks
Intervention Description
350 cc (1 can) of artificially sweetened beverage
Primary Outcome Measure Information:
Title
Insulin sensibility
Description
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.
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.
Secondary Outcome Measure Information:
Title
Glycemic response
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romina A Goza Ferreira, Magister c
Phone
+56950088329
Email
rominagoza@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Hirsch Birn, Magister
Phone
+56229781495
Ext
+56229781499
Email
shirsch@inta.uchile.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romina A Goza Ferreira, Magister c
Organizational Affiliation
Institute of Nutrition and Tecnology of Food, University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Hirsch Birn, Magister
Organizational Affiliation
Institute of Nutrition and Tecnology of Food, University of Chile
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Nutrition and Tecnology of Food, University of Chile
City
Santiago
State/Province
Metropolitan region
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Verónica Cornejo Espinoza, Director
Phone
+56229781 410
Email
vcornejo@inta.uchile.cl
First Name & Middle Initial & Last Name & Degree
Sandra Hirsch Birn, Academic
Phone
+56229781495
Ext
+56229781499
Email
shirsch@inta.uchile.cl
First Name & Middle Initial & Last Name & Degree
Romina A Goza Ferreira, Magister c
First Name & Middle Initial & Last Name & Degree
Sandra Hirsch Birn, Magister
First Name & Middle Initial & Last Name & Degree
Gladys Barrera Acevedo, Magister

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All the data is confidential and only will be show if ethics committee ask for it
Citations:
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Results Reference
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Results Reference
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Citation
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Citation
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Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

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