- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679689
Metabolism Effects of Artificially Sweetened Beverages Restriction
Improvement of Biochemical Markers After Reduction of Artificially Sweetened Beverages Consumption. A Clinical Randomised Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Veracruz
-
Xalapa, Veracruz, Mexico, 91190
- Universidad Veracruzana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
no changes in their alimentary habits
|
|
Experimental: intervention group
no intake of artificially sweetened beverages
|
artificially sweetened beverages restriction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose in mg/dl
Time Frame: 12 weeks
|
Fasting blood samples will be analyzed for plasma concentrations
|
12 weeks
|
Triglycerides in mg/dl
Time Frame: 12 weeks
|
Fasting blood samples will be analyzed for plasma concentrations
|
12 weeks
|
Insulin
Time Frame: 12 weeks
|
Fasting blood samples will be analyzed for plasma concentrations
|
12 weeks
|
Cholesterol in mg/dl
Time Frame: 12 weeks
|
Fasting blood samples will be analyzed for plasma concentrations
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Micro and macronutrients consumed during the 12 week study (in grams)
Time Frame: 12 weeks
|
24-hour recall
|
12 weeks
|
Weight in kilograms
Time Frame: 12 weeks
|
bioelectrical impedance
|
12 weeks
|
Body fat percentage
Time Frame: 12 weeks
|
bioelectrical impedance
|
12 weeks
|
Portions consumed of artificially sweetened beverages (1portion=250ml)
Time Frame: 12 weeks
|
food frequency instrument
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Monica Flores-Muñoz, PhD, Universidad Veracruzana
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D_005/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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