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

Primary Purpose

Obesity and Overweight

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Caloric and non-caloric SSBS reduction
Caloric SSBS reduction
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity and Overweight focused on measuring Beverages sweetened caloric, no caloric, Weight, Fat percentage, Body Composition, Blood pressure, Sugar, Sodium, Dietary intake

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • INCMNSZ

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Caloric and non-caloric SSBS reduction

Caloric SSBS reduction

All beverages

Arm Description

Sweetened beverages (SSBS) caloric and non-caloric were not permitted and allowed only plain water

Only plain water and non-caloric sweetened beverages (SSBS) were allowed

Beverages were not restricted

Outcomes

Primary Outcome Measures

Percentage of change from baseline in kilograms of weight

Secondary Outcome Measures

Percentage of change from baseline in diastolic blood pressure
Percentage of change from baseline in systolic blood pressure

Full Information

First Posted
January 16, 2015
Last Updated
January 26, 2015
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02347267
Brief Title
Reduction in Consumption of Sweetened Beverages on Weight, Body Composition and Blood Pressure in Young Adults
Official Title
The Impact of Reduction in Consumption of Caloric and no Caloric Sweetened Beverages on Weight, Body Composition and Blood Pressure in Young Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The impact of reduction in consumption of caloric and no caloric sweetened beverages on: weight body composition blood pressure young adults
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Overweight
Keywords
Beverages sweetened caloric, no caloric, Weight, Fat percentage, Body Composition, Blood pressure, Sugar, Sodium, Dietary intake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caloric and non-caloric SSBS reduction
Arm Type
Experimental
Arm Description
Sweetened beverages (SSBS) caloric and non-caloric were not permitted and allowed only plain water
Arm Title
Caloric SSBS reduction
Arm Type
Active Comparator
Arm Description
Only plain water and non-caloric sweetened beverages (SSBS) were allowed
Arm Title
All beverages
Arm Type
No Intervention
Arm Description
Beverages were not restricted
Intervention Type
Behavioral
Intervention Name(s)
Caloric and non-caloric SSBS reduction
Intervention Description
Isocaloric individualized diet and sweetened caloric and non-caloric beverages restriction
Intervention Type
Behavioral
Intervention Name(s)
Caloric SSBS reduction
Intervention Description
Isocaloric individualized diet and caloric SSBS restriction
Primary Outcome Measure Information:
Title
Percentage of change from baseline in kilograms of weight
Time Frame
Baseline to three and six months
Secondary Outcome Measure Information:
Title
Percentage of change from baseline in diastolic blood pressure
Time Frame
Baseline to three and six months follow-up
Title
Percentage of change from baseline in systolic blood pressure
Time Frame
Baseline to three and six months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisela Vázquez Duran, M.Sc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lilia Castillo Martinez, M.Sc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arturo Orea Tejeda, M.D
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
Facility Information:
Facility Name
INCMNSZ
City
Mexico
State/Province
Distrito Federal
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18372998
Citation
Rivera JA, Munoz-Hernandez O, Rosas-Peralta M, Aguilar-Salinas CA, Popkin BM, Willett WC; Comite de Expertos para las Recomendaciones. [Beverage consumption for a healthy life: recommendations for the Mexican population]. Salud Publica Mex. 2008 Mar-Apr;50(2):173-95. doi: 10.1590/s0036-36342008000200011. Spanish.
Results Reference
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PubMed Identifier
15051594
Citation
Bray GA, Nielsen SJ, Popkin BM. Consumption of high-fructose corn syrup in beverages may play a role in the epidemic of obesity. Am J Clin Nutr. 2004 Apr;79(4):537-43. doi: 10.1093/ajcn/79.4.537. Erratum In: Am J Clin Nutr. 2004 Oct;80(4):1090.
Results Reference
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PubMed Identifier
20420761
Citation
Ma J, Chang J, Checklin HL, Young RL, Jones KL, Horowitz M, Rayner CK. Effect of the artificial sweetener, sucralose, on small intestinal glucose absorption in healthy human subjects. Br J Nutr. 2010 Sep;104(6):803-6. doi: 10.1017/S0007114510001327. Epub 2010 Apr 27.
Results Reference
background
PubMed Identifier
19087367
Citation
Gibson S. Sugar-sweetened soft drinks and obesity: a systematic review of the evidence from observational studies and interventions. Nutr Res Rev. 2008 Dec;21(2):134-47. doi: 10.1017/S0954422408110976.
Results Reference
background
PubMed Identifier
17329656
Citation
Vartanian LR, Schwartz MB, Brownell KD. Effects of soft drink consumption on nutrition and health: a systematic review and meta-analysis. Am J Public Health. 2007 Apr;97(4):667-75. doi: 10.2105/AJPH.2005.083782. Epub 2007 Feb 28.
Results Reference
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Reduction in Consumption of Sweetened Beverages on Weight, Body Composition and Blood Pressure in Young Adults

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