Status:
COMPLETED
Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women
Lead Sponsor:
Mexican National Institute of Public Health
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Danone Global Research & Innovation Center
Conditions:
Metabolic Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
NA
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...
Detailed Description
Study subjects The investigators propose to recruit young adult women aged 18-45 y who are overweight or obese (BMI \>25 and \<39), with fasting triglyceride level \> 150 mg/dl, and consume at least ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01245010
Start Date
April 1 2009
End Date
August 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
National Institute of Public Health
Cuernavaca, Morelos, Mexico, 62100