Metabolism Effects of Artificially Sweetened Beverages Restriction
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

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.
    

Intervention name(s): artificially sweetened beverages
Intervention type(s): Dietary Supplement
Intervention description(s): artificially sweetened beverages restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, blind, controlled clinical trial
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Non-Nutritive sweeteners; Artificially sweeteners; obesity; overweight