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Metabolism Effects of Artificially Sweetened Beverages Restriction

Improvement of Biochemical Markers After Reduction of Artificially Sweetened Beverages Consumption. A Clinical Randomised Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03679689
Enrollment
45
Registered
2018-09-20
Start date
2017-02-01
Completion date
2019-01-31
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Non-Nutritive sweeteners, Artificially sweeteners, obesity, overweight

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.

Interventions

artificially sweetened beverages restriction

Sponsors

Universidad Veracruzana
CollaboratorOTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
CollaboratorOTHER
Monica Flores-Muñoz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Nobody involved with data acquisition had access to de assignment of the subjects

Intervention model description

A randomized, blind, controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
19 Years to 27 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cholesterol in mg/dl12 weeksFasting blood samples will be analyzed for plasma concentrations
Glucose in mg/dl12 weeksFasting blood samples will be analyzed for plasma concentrations
Triglycerides in mg/dl12 weeksFasting blood samples will be analyzed for plasma concentrations
Insulin12 weeksFasting blood samples will be analyzed for plasma concentrations

Secondary

MeasureTime frameDescription
Micro and macronutrients consumed during the 12 week study (in grams)12 weeks24-hour recall
Weight in kilograms12 weeksbioelectrical impedance
Body fat percentage12 weeksbioelectrical impedance
Portions consumed of artificially sweetened beverages (1portion=250ml)12 weeksfood frequency instrument

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026