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Metabolism Effects of Artificially Sweetened Beverages Restriction

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
artificially sweetened beverages
Sponsored by
Monica Flores-Muñoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Non-Nutritive sweeteners, Artificially sweeteners, obesity, overweight

Eligibility Criteria

19 Years - 27 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI between 25 kg /m² to 36 kg / m², with low intensity physical activities and consumers of at least 3 portions of artificially sweetened beverages per week

Exclusion Criteria:

  • students with hyper or hypothyroidism, pregnant women and those who perform high to moderate physical activities

Sites / Locations

  • Universidad Veracruzana

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

intervention group

Arm Description

no changes in their alimentary habits

no intake of artificially sweetened beverages

Outcomes

Primary Outcome Measures

Glucose in mg/dl
Fasting blood samples will be analyzed for plasma concentrations
Triglycerides in mg/dl
Fasting blood samples will be analyzed for plasma concentrations
Insulin
Fasting blood samples will be analyzed for plasma concentrations
Cholesterol in mg/dl
Fasting blood samples will be analyzed for plasma concentrations

Secondary Outcome Measures

Micro and macronutrients consumed during the 12 week study (in grams)
24-hour recall
Weight in kilograms
bioelectrical impedance
Body fat percentage
bioelectrical impedance
Portions consumed of artificially sweetened beverages (1portion=250ml)
food frequency instrument

Full Information

First Posted
September 14, 2018
Last Updated
August 4, 2022
Sponsor
Monica Flores-Muñoz
Collaborators
Universidad Veracruzana, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT03679689
Brief Title
Metabolism Effects of Artificially Sweetened Beverages Restriction
Official Title
Improvement of Biochemical Markers After Reduction of Artificially Sweetened Beverages Consumption. A Clinical Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Monica Flores-Muñoz
Collaborators
Universidad Veracruzana, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The consumption of artificially sweetened beverages increases glucose and insulin concentrations in blood, body weight and waist circumference. However, the effect of restricting the consumption of these beverages on metabolism is unknown. Our objective is to evaluate the effect of reducing artificially sweetened beverages consumption on the metabolism of overweight and obese young adults. A randomized, blind, controlled 12 week clinical trial will be performed on overweight and obese young adults. Young adults, consumers of artificially sweetened beverages, will be randomly assign to either Control group (no changes in their alimentary habits) or Intervention group (no intake of artificially sweetened beverages). The percentage change between 0 and 12 weeks of anthropometric variables, fasting plasma concentrations of glucose, triglycerides, insulin and cholesterol will be calculated and compared.
Detailed Description
Overweight and obesity are public health problems across the world. In 2016 the World Health Organization estimated that over 1900 million adults were diagnosed as overweight or obese. These pathologies result from the interaction between many factors, mainly poor alimentary habits and a sedentary lifestyle. The high consumption of simple carbohydrates and sugar sweetened beverages, like soft drinks, juices and flavored water, is considered one of the main factors that contribute to the increase in incidence and prevalence of overweight and obesity. A high consumption of simple carbohydrates promotes an increase in blood glucose concentrations, which facilitates the formation of triglycerides that are subsequently stored in adipose tissue. To decrease the caloric intake attributable to sugar sweetened beverages, the food industry promotes the commercialization of artificially sweetened beverages. These products have the same organoleptic features than sugar sweetened beverages, with the perks of having a minimum or no caloric contribution at all, not affecting the energy metabolism. Nonetheless, recent studies relate the consumption of artificially sweetened beverages with a deregulation of the metabolic homeostasis, promoting physiological modifications. Likewise, it was reported that artificial sweeteners increased glucose and insulin concentrations in blood, which is detrimental to health, especially in population with a pre-existing risk of developing non-infectious diseases, such as overweight and obesity. For this reason we will evaluate the effect of reducing the consumption of artificially sweetened beverages (ASBs) in overweight and obese young adults. This study is a single-blind randomized clinical trial controlled with a parallel group. Young adults, students of the University of Veracruz, are randomly allocated to a 12-week no consumption of artificially sweetened beverages intervention or control group. All the volunteers that satisfy the inclusion criteria will be asked to sign the informed consent before the start of the study. The volunteers will be randomly allocated in control or intervention group (1:1 allocation ratio to each group) in blocks of 2 using Microsoft Office Excell. Nobody involved with data acquisition will have access to the assignment of the participants. Once randomly assigned, a blood sample and anthropometric variables will be taken to establish basal data. Participants will be interviewed to know caloric intake (24-h food recall), consumed portions and beverage consumption (Food frequency questionnaire). The intervention group will not be allowed to consume artificially sweetened beverages; however, they will be allowed to consume products that do not contain artificial sweeteners in their formulae. For the control group artificially sweetened beverages consumption will not be modified. Both groups will continue with their normal food habits. Anthropometric measures, 24-h food recall and food frequency questionnaire data will be collected at week 0, 6 and 12. A blood sample will be taken at week 0 and 12. In order to categorize the physical activity a, previously validated, questionnaire will applied. Using this instrument, physical level will be divided in low, moderate and high. For comparison between groups at baseline measurements we will use Student´s t-test and Mann- Whitney U test based on data distribution. In order to compare changes between baseline and 12 weeks measurements, the percentage change will be calculate, and pertinent tests applied. A p value <0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Non-Nutritive sweeteners, Artificially sweeteners, obesity, overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, blind, controlled clinical trial
Masking
Investigator
Masking Description
Nobody involved with data acquisition had access to de assignment of the subjects
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
no changes in their alimentary habits
Arm Title
intervention group
Arm Type
Experimental
Arm Description
no intake of artificially sweetened beverages
Intervention Type
Dietary Supplement
Intervention Name(s)
artificially sweetened beverages
Intervention Description
artificially sweetened beverages restriction
Primary Outcome Measure Information:
Title
Glucose in mg/dl
Description
Fasting blood samples will be analyzed for plasma concentrations
Time Frame
12 weeks
Title
Triglycerides in mg/dl
Description
Fasting blood samples will be analyzed for plasma concentrations
Time Frame
12 weeks
Title
Insulin
Description
Fasting blood samples will be analyzed for plasma concentrations
Time Frame
12 weeks
Title
Cholesterol in mg/dl
Description
Fasting blood samples will be analyzed for plasma concentrations
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Micro and macronutrients consumed during the 12 week study (in grams)
Description
24-hour recall
Time Frame
12 weeks
Title
Weight in kilograms
Description
bioelectrical impedance
Time Frame
12 weeks
Title
Body fat percentage
Description
bioelectrical impedance
Time Frame
12 weeks
Title
Portions consumed of artificially sweetened beverages (1portion=250ml)
Description
food frequency instrument
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI between 25 kg /m² to 36 kg / m², with low intensity physical activities and consumers of at least 3 portions of artificially sweetened beverages per week Exclusion Criteria: students with hyper or hypothyroidism, pregnant women and those who perform high to moderate physical activities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Flores-Muñoz, PhD
Organizational Affiliation
Universidad Veracruzana
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Veracruzana
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91190
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34986271
Citation
Bergwall S, Johansson A, Sonestedt E, Acosta S. High versus low-added sugar consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2022 Jan 5;1(1):CD013320. doi: 10.1002/14651858.CD013320.pub2.
Results Reference
derived

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Metabolism Effects of Artificially Sweetened Beverages Restriction

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