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Obesity and OverweightNCT02347267

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

A study testing Caloric and non-caloric SSBS reduction and Caloric SSBS reduction in people with Obesity and Overweight, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The impact of reduction in consumption of caloric and no caloric sweetened beverages on: weight body composition blood pressure young adults Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Obesity and Overweight
What is being tested?
Caloric and non-caloric SSBS reduction and Caloric SSBS reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteMexico
Study dates
May 2012to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • INCMNSZ

    Mexico City, Mexico City

Other trials in Mexico

About this study

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.

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

  • weight
  • body composition
  • blood pressure
  • young adults
Read the 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.

Being tested
Caloric and non-caloric SSBS reduction, Caloric SSBS reduction
Keywords
Beverages sweetened caloric, no caloric, Weight, Fat percentage, Body Composition, Blood pressure, Sugar, Sodium, Dietary intake
Medical subject headings
Obesity, Overweight, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caloric and non-caloric SSBS reductionBehavioural

    Isocaloric individualized diet and sweetened caloric and non-caloric beverages restriction

  • Caloric SSBS reductionBehavioural

    Isocaloric individualized diet and caloric SSBS restriction

Study groups in NCT02347267
Study groupRoleWhat they receive
Caloric and non-caloric SSBS reductionExperimentalSweetened beverages (SSBS) caloric and non-caloric were not permitted and allowed only plain water
Receives: Behavioral: Caloric and non-caloric SSBS reduction
Caloric SSBS reductionActive comparatorOnly plain water and non-caloric sweetened beverages (SSBS) were allowed
Receives: Behavioral: Caloric SSBS reduction
All beveragesNo interventionBeverages were not restricted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of change from baseline in kilograms of weight

    Measured: Baseline to three and six months

Secondary outcomes (2)

  1. Percentage of change from baseline in diastolic blood pressure

    Measured: Baseline to three and six months follow-up

  2. Percentage of change from baseline in systolic blood pressure

    Measured: Baseline to three and six months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2015 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2012
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02347267
Sponsor's protocol ID
Clic 002
Status last verified
Jan 2015
First submitted
16 Jan 2015
Last updated
28 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18372998

  • 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.

    PubMed 15051594

  • 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.

    PubMed 20420761

  • 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.

    PubMed 19087367

  • 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.

    PubMed 17329656

Questions about this trial

What is this clinical trial studying?

A study testing Caloric and non-caloric SSBS reduction and Caloric SSBS reduction in people with Obesity and Overweight, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of change from baseline in kilograms of weight (time frame: Baseline to three and six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347267, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.

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