Improvement of Biochemical Markers After Reduction of Artificially Sweetened Beverages Consumption. A Clinical Randomised Trial
Phase: NA
Conditions: Overweight and Obesity
Sponsor: Monica Flores-Muñoz

 
 
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Improvement of biochemical markers after reduction of artificially 
sweetened beverages consumption. A clinical randomised trial 
 
 
 
 
 
 
 
 
 
 
 
February, 2018 

 
 
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Introduction 
Overweight and obesity are public health problems across the world. In 2016 the World 
Health Organization (WHO) estimated that over 1900 million adults were diagnosed as 
overweight or obese (1). Currently, these pathologies are associated with the risk of 
developing pathologies such as insulin resistance, Type 2 Diabetes Mellitus(T2DM) and 
Metabolic Syndrome (2). 
These pathologies result from the interaction between many factors, mainly poor 
alimentary habits and a sedentary lifestyle (2-4). The high consumption of simple 
carbohydrates and sugar sweetened beverages (SSBs), 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 glucose concentrations in blood, which facilitates 
the formation of triglycerides that are subsequently stored in adipose tissue (2, 4, 5). 
Mexico is the Latin American country with the highest consumption of SSBs. It was 
estimated that the intake per person was 384 SSBs per year (6). The exact figures of 
the population that consumes ASBs are not known. However, an increase in the 
consumption of products containing artificial sweeteners (ASs) was reported (7, 8). In 
Mexico, more than 70% of the adult population has been diagnosed as overweight or 
obese (1). 
To decrease the caloric intake attributable to SSBs, the food industry promotes the 
commercialization of ASBs (9). These products have the same organoleptic features 
than SSBs, with the perks of having a minimum or no caloric contribution at all, not 

 
 
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affecting the energy metabolism (10). For this reason, in Mexico the official treatment 
guidelines for overweight and obesity recommend it use as part of the nutritional 
treatment (11). 
Nonetheless, recent studies relate the consumption of ASBs with a deregulation of the 
metabolic homeostasis, promoting physiological modifications (12). In a study 
conducted by Duran, et. al. aiming to evaluate the effect of the reduction of SSBs and 
ASBs, concluded that the reduction in the consumption of these beverages decreased 
weight and body fat (13). On the other hand, Madjad, et. al. reported a decrease in body 
weight of women with type 2 diabetes mellitus after substituting the consumption of 
ASBs, for water (14). Some cohort studies reported an association between the 
consumption of ASBs and the increase in body weight and waist circumference (4, 15). 
Likewise, it was reported that ASs 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 (12, 16-18). 
While population increases the consumption of ASBs, the prevalence of overweight and 
obesity increased too. To contribute to the knowledge on the effect of these substances 
in the human body, we evaluated the effect of reducing the consumption of ASBs in 
overweight and obese young adults. 
 
 
 
 

 
 
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Objective 
Evaluate the effect of restriction ASBs consumption on the metabolism in overweight 
and obese young adults  
Hypothesis 
The restriction of ASBs in young people who consume them and who present 
overweight and obesity, decrease an anthropometric data, and biochemical markers. 
Design and methods 
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Study Design 
This study is a single-blind randomized clinical trial it will perform at the University of 
Veracruz, Veracruz, Mexico, between February 2017 to October 2018. Young adults 
students of the University of Veracruz will randomly allocate to a 12-week no 
consumption of ASBs intervention or control group. 
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Randomization and intervention procedure 
All the volunteers that will meet the inclusion criteria will sign the informed consent 
before the study started. The volunteers will randomly allocate in control or intervention 
group (1:1 allocation ratio to each group) in blocks of 2 by using Microsoft Office Excell. 
Nobody involved with data acquisition will have access to de assignment of the 
subjects. Once randomly assigned, a blood sample and anthropometric variables will 
take to establish basal data. Participants will interview to know, caloric intake (24-h food 
recall), consumed portions and beverage consumption (Food frequency questionnaire). 
The intervention group is not allowed to consume ASBs, however they are allow 
consuming products that did not contain ASs in their formulae. For the control group 
ASBs consumption are not modified. Both groups continue the normal food habits. 

 
 
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Anthropometric measures, 24-h food recall and food frequency questionnaire data will 
collect at week 6 and 12. Blood sample will take once more at study week 12. In order 
to categorize the physical activity a previously validated questionnaire will apply, the 
physical level are divide in low, moderate and high. 
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Study population 
Young overweight or obese students between 19 and 27 years old with normally 
consumption of ASBs 
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Sample 
It is a probabilistic, stratified sampling that is made from the overweight and obese 
population who consume ASbs. 
The data for obtaining the sample will be collected from the questionnaires that will be 
applied to the students in which we will know who consume ASBs. 
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Statistic 
They will be analyzed with the statistical program SPSS 21. With a two-way analysis of 
variance ANOVA or T-student test with repeated measures. And the variables will be 
correlated.  
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Ethical and biosecurity considerations  
According to the Regulation of the General Health Law on Health Research, which was 
enacted in 1984 by Miguel de la Madrid in his third article, research for health includes 
the development of actions that contribute; to the knowledge of the biological and 
psychological processes of humans, to the knowledge of the links to the causes of 
illness, the medical practice and the social structure, to the prevention and control of 
health problems, to the knowledge and evaluation of the harmful effects of health 
environment, to the study of the techniques and methods that are recommended or 
used for the provision of health services, and to the production of supplies for health. 

 
 
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According to article 13 of this law, in any investigation in which the human being is 
subject to the study, the criterion of respect for their dignity and the protection of their 
rights and welfare must prevail. 
According to article 16 in the investigations of human beings the privacy of the individual 
subject to the investigation will be protected, identifying it only when the result requires it 
and this authorizes. 
According to article 17 in its second section, this research is considered as minimal risk 
since the risk of data is used through common procedures, physical or psychological 
diagnostic tests or routine treatments. 
For what subject to the law, the informed consent letter will be provided to the research 
prospectus, which will be delivered prior to the application of the questionnaire. For the 
application of the questionnaire will pass through each classroom of the Faculty of 
Nutrition and Biochemistry of the Veracruz University Veracruz campus, which will be 
carried out after authorization by the authorities of each faculty. Likewise, the subject 
will be given a clear and concise explanation of the objectives of the research, the 
benefits, the inconveniences or risks expected the procedures that will be used, its 
purpose and the previous investigations that have been carried out on the subject, as 
well as those that arise during the time of the study. This process will be in charge of the 
main researcher of the project.  
The prospect should be aware that he is at liberty to withdraw his consent at any time, 
and that the information collected during the investigation will be used only by the 
research group who will replace his name with a code to guarantee the confidentiality of 
the data. 
Only the principal investigator of this project acquires the commitment with the 
participating subjects to continue with a nutritional follow-up during the 3 months after 
the end of the study, which includes a personalized nutritional plan, which will be 
obtained from anthropometric measurements. In the same way, the researcher commits 
to provide the results of the analysis of the biochemical values that are carried out at the 
beginning and at the end of the project. 

 
 
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To present the results obtained in the research to the participating subjects and the 
Health Services Studies Center, a summary of the most relevant data of the study 
signed by the main researcher will be made, which will be sent to them by email or will 
deliver them in a personal way according to the preference of the subject and the 
institution. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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