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Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women

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ClinicalTrials.gov Identifier: NCT01245010
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:

Research Question: Does replacing Sugar Sweetened (SS) beverages with water consumption promote a decrease in triglycerides blood levels over 9 months in overweight women? The primary outcome variable is the triglycerides blood level. In addition, the investigators will consider as secondary outcome variables the following parameters of metabolic syndrome: weight, fasting insulin and glucose, HOMA, HDL-cholesterol, systolic and diastolic blood pressure, and waist circumference. The investigators will also consider as an outcome variable glycosylated (or glycated) hemoglobin (HbA1c).

Design: Two groups randomized controlled trial, with an intervention group (water and education provision) and control group (education provision only).

The investigators propose to recruit young adult women aged >18-<45 y who are overweight or obese (BMI >25 and <39), and consume at least 250 calories per day from caloric beverages (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic beverages) The intervention group (water and education provision) will be compared with a control condition (education provision only). The intervention has been proposed to be carried out for 9 months period with objective measurements of body weight and fat, total cholesterol, LDL-C, HDL-C, fasting blood glucose, HbA1C, hydration status, blood pressure, and 24 hrs dietary recalls at baseline, 3,6 and 9 months

Condition or disease Intervention/treatment
Metabolic Syndrome Other: Water Other: Education

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of a Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women
Study Start Date : April 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Arms and Interventions

Arm Intervention/treatment
Experimental: Water
Water and education provision
Other: Water
Water and education will be provided
Other Name: Water and education
Active Comparator: Control
Education only
Other: Education
Other Name: Education only

Outcome Measures

Primary Outcome Measures :
  1. Triglycerides blood level [ Time Frame: baseline ]
  2. Triglycerides blood levels [ Time Frame: 3 months ]
  3. Triglycerides blood Levels [ Time Frame: 6 months ]
  4. Triglycerides blood levels [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Body weight [ Time Frame: Baseline ]
  2. Fasting insulin [ Time Frame: Baseline ]
  3. Fasting glucose [ Time Frame: Baseline ]
  4. Homeostasis Model Assessment (HOMA) [ Time Frame: Baseline ]
  5. HDL-cholesterol [ Time Frame: Baseline ]
  6. Systolic and diastolic blood pressure [ Time Frame: Baseline ]
  7. Waist circumference [ Time Frame: Baseline ]
  8. Glycosylated (or glycated) hemoglobin (HbA1c) [ Time Frame: Baseline ]
  9. Boby Weight [ Time Frame: 3 months ]
  10. Body weight [ Time Frame: 6 months ]
  11. Body weight [ Time Frame: 9 months ]
  12. Fasting insulin [ Time Frame: 3 months ]
  13. Fasting insulin [ Time Frame: 6 months ]
  14. Fasting insulin [ Time Frame: 9 months ]
  15. Fasting glucose [ Time Frame: 3 months ]
  16. Fasting glucose [ Time Frame: 6 months ]
  17. Fasting glucose [ Time Frame: 9 months ]
  18. Homeostasis Model Assessment (HOMA) [ Time Frame: 3 months ]
  19. Homeostasis Model Assessment (HOMA) [ Time Frame: 6 months ]
  20. Homeostasis Model Assessment (HOMA) [ Time Frame: 9 months ]
  21. HDL-cholesterol [ Time Frame: 3 months ]
  22. HDL-cholesterol [ Time Frame: 6 months ]
  23. HDL-cholesterol [ Time Frame: 9 months ]
  24. Systolic and diastolic blood pressure [ Time Frame: 3 months ]
  25. Systolic and diastolic blood pressure [ Time Frame: 6 months ]
  26. Systolic and diastolic blood pressure [ Time Frame: 9 months ]
  27. Waist circumference [ Time Frame: 3 months ]
  28. Waist circumference [ Time Frame: 6 months ]
  29. Waist circumference [ Time Frame: 9 months ]
  30. Glycosylated (or glycated) hemoglobin (HbA1c) [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Young adult women aged >18-<45 y
  • BMI >25 and <39
  • Consume at least 250 calories per day from caloric beverage
  • Women planning to live in the study area over the next year
  • Willingness to participate in the required evaluations
  • Women have given their consent to participate

Exclusion Criteria:

  • Report losing >5% of current body weight in the previous 6 months. Individuals who have recently lost significant body weight may be at high risk for weight regain, which could result in this study examining prevention of weight regain rather than weight loss.
  • If they report to be on a diet to reduce weight at the time of recruitment
  • Report pregnancy during the previous 6 months or if they are lactating at the time of recruitment or they are planning to become pregnant in the following 12 months.
  • Report current treatment for any medical condition that could impact metabolic function (e.g.., diabetes mellitus, cancer, Etc.).
  • History of myocardial infarction or heart surgery such as bypass or angioplasty. These individuals will be excluded because this may require additional medical monitoring and adjustments to the exercise prescription.
  • Report taking any type of medication that could affect metabolism, energy intake or change body weight (e.g., hypothyroidism).
  • Report hospitalization for psychiatric problems prior year to the enrollment period.
  • If they are on a regime to increase muscle mass or taking anabolics
  • Excessive consumption of alcoholic beverages, defined as 21 or more drinks per week
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245010

National Institute of Public Health
Cuernavaca, Morelos, Mexico, 62100
Sponsors and Collaborators
Mexican National Institute of Public Health
University of North Carolina, Chapel Hill
Danone Research
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonia Hernandez-Cordero, Head of the Deparment of Community Nutrition, Mexican National Institute of Public Health
ClinicalTrials.gov Identifier: NCT01245010     History of Changes
Other Study ID Numbers: 755
CINYS 812 ( Other Identifier: INSP )
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Sonia Hernandez-Cordero, Mexican National Institute of Public Health:
Metabolic Syndrome
Clinical trial

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases