Clinical trial NCT02347267: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity and Overweight
Keywords: Beverages sweetened caloric, no caloric
Weight
Fat percentage
Body Composition
Blood pressure
Sugar
Sodium
Dietary intake
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of change from baseline in kilograms of weight
timeFrame: Baseline to three and six months
Secondary outcomes:
measure: Percentage of change from baseline in diastolic blood pressure
timeFrame: Baseline to three and six months follow-up
measure: Percentage of change from baseline in systolic blood pressure
timeFrame: Baseline to three and six months follow-up
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: INCMNSZ
state: Distrito Federal
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Marisela Vázquez Duran, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Lilia Castillo Martinez, M.Sc
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Arturo Orea Tejeda, M.D
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.