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

NCT01245010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-10-12

No results posted yet for this study

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

Conditions

  • Metabolic Syndrome

Interventions

OTHER

Water

Water and education will be provided

OTHER

Education

Education

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Danone Global Research & Innovation Center

    collaborator INDUSTRY

  • Mexican National Institute of Public Health

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245010 on ClinicalTrials.gov