NCT02347267

Brief Summary

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

  • weight
  • body composition
  • blood pressure
  • young adults

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

January 16, 2015

Last Update Submit

January 26, 2015

Conditions

Keywords

Beverages sweetened caloric, no caloricWeightFat percentageBody CompositionBlood pressureSugarSodiumDietary intake

Outcome Measures

Primary Outcomes (1)

  • Percentage of change from baseline in kilograms of weight

    Baseline to three and six months

Secondary Outcomes (2)

  • Percentage of change from baseline in diastolic blood pressure

    Baseline to three and six months follow-up

  • Percentage of change from baseline in systolic blood pressure

    Baseline to three and six months follow-up

Study Arms (3)

Caloric and non-caloric SSBS reduction

EXPERIMENTAL

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

Behavioral: Caloric and non-caloric SSBS reduction

Caloric SSBS reduction

ACTIVE COMPARATOR

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

Behavioral: Caloric SSBS reduction

All beverages

NO INTERVENTION

Beverages were not restricted

Interventions

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

Caloric and non-caloric SSBS reduction

Isocaloric individualized diet and caloric SSBS restriction

Caloric SSBS reduction

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCMNSZ

Mexico City, Mexico City, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 18372998BACKGROUND
  • 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.

    PMID: 15051594BACKGROUND
  • 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.

    PMID: 20420761BACKGROUND
  • 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.

    PMID: 19087367BACKGROUND
  • 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.

    PMID: 17329656BACKGROUND

MeSH Terms

Conditions

ObesityOverweightBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marisela Vázquez Duran, M.Sc

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
at the National Institute of Medical Science and Nutrition Salvador Zubiran

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 27, 2015

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

February 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations