Reduction in Consumption of Sweetened Beverages on Weight, Body Composition and Blood Pressure in Young Adults

January 26, 2015 updated by: LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

The Impact of Reduction in Consumption of Caloric and no Caloric Sweetened Beverages on Weight, Body Composition and Blood Pressure in Young Adults.

The impact of reduction in consumption of caloric and no caloric sweetened beverages on:

  • weight
  • body composition
  • blood pressure
  • young adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The number of overweight and obese individuals has recently increased considerably. The World Health Organization estimates that there are 1.4 billion overweight and obese people in the world (1); in Mexico alone 70% of the adult population suffers from overweight and obesity, and 34.4% of school age children are above their normal weight (2) At the same time, hypertension affects more than a third of adults throughout the world and contributes to 9.4 million deaths a year from heart disease (3). In Mexico there are 22.4 million adults with hypertension, only 5.7 of whom are controlled (4). Obesity and hypertension are associated with life style both in the world and in Mexico, where changes in eating habits with increased fat in the diet, overconsumption of soft drinks and refined sugars and decrease in physical activity have led to numerous diseases (4). Mexico is the Latin American country with the highest consumption of carbonated beverages (5), averaging 384 soft drinks/person/year (6). The diminished sensation of satiety and the high ingestion of simple sugars (7, 8) facilitate the formation of triglycerides stored in fatty tissue and overweight and obesity (9, 10). Recent studies have examined the relationship between beverages and weight, albeit with controversial results. The majority of the studies have focused on increased consumption of sweetened drinks and their effect on weight over short periods of time (11,13,14). Meanwhile, consumption of low calorie beverages has increased, although there is no consensus about the utility of substituting sugar with artificial sweeteners to achieve better weight control (13). As much as obesity is a world-wide health issue, it is important to establish whether beverages with artificial sweeteners can aid in regulating weight. Since soft drinks contain sodium, it is also important to determine whether elevated sodium ingestion from them could increase blood pressure. Recent studies have demonstrated an association between sugar sweetened beverages and blood pressure, but the majority have been observational (14) and have not analyzed all types of sweetened beverages (15, 16).Because of these issues, the objective of the present study was to characterize the effect of reducing the consumption of beverages with sugar and artificial sweeteners on weight and blood pressure on nursing students. The working hypothesis was that nursing students from the National Institute of Medical Science and Nutrition in Mexico City (INCMNSZ) who substituted their intake of sugar or artificially sweetened soft drinks with plain water would have greater weight loss, lower fat and lower blood pressure than students who did not diminish their intake of soft drinks.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • INCMNSZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Students in the Bachelor of Nursing INCMNSZ. What made light and moderate physical activity no more than 1 hour of exercise.

That according to the survey conducted consume at least one sugary drink according to the recommendations of the Ministry of Health

Exclusion Criteria:

Subjects who currently have or meet a specific diet. Diagnosed with hypertension or utilization of antihypertensive drugs. Hyperthyroidism and hypothyroidism. Use of drugs for weight loss. Diabetes mellitus History of cardiovascular events. Peripheral vascular disease. Cancer. Renal damage Psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caloric and non-caloric SSBS reduction
Sweetened beverages (SSBS) caloric and non-caloric were not permitted and allowed only plain water
Behavioral: Caloric and non-caloric SSBS reduction
Isocaloric individualized diet and sweetened caloric and non-caloric beverages restriction
Active Comparator: Caloric SSBS reduction
Only plain water and non-caloric sweetened beverages (SSBS) were allowed
Behavioral: Caloric SSBS reduction
Isocaloric individualized diet and caloric SSBS restriction
No Intervention: All beverages
Beverages were not restricted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of change from baseline in kilograms of weight
Time Frame: Baseline to three and six months
Baseline to three and six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of change from baseline in diastolic blood pressure
Time Frame: Baseline to three and six months follow-up
Baseline to three and six months follow-up
Percentage of change from baseline in systolic blood pressure
Time Frame: Baseline to three and six months follow-up
Baseline to three and six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Marisela Vázquez Duran, M.Sc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Study Director: Lilia Castillo Martinez, M.Sc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Study Director: Arturo Orea Tejeda, M.D, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clic 002

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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