Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

August 31, 2016 updated by: Romina Goza Ferreira, Instituto de Nutrición y Tecnología de los Alimentos
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitan region
      • Santiago, Metropolitan region, Chile
        • Recruiting
        • Institute of Nutrition and Tecnology of Food, University of Chile
        • Contact:
        • Contact:
        • Principal Investigator:
          • Romina A Goza Ferreira, Magister c
        • Principal Investigator:
          • Sandra Hirsch Birn, Magister
        • Sub-Investigator:
          • Gladys Barrera Acevedo, Magister

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Artificially sweetened drinks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EANC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All the data is confidential and only will be show if ethics committee ask for it

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Sensitivity

Clinical Trials on Sugar sweetened beverages

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe