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

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Danone Research
Information provided by (Responsible Party):
Sonia Hernandez-Cordero, Mexican National Institute of Public Health
ClinicalTrials.gov Identifier:
NCT01245010
First received: May 20, 2010
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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 Intervention
Metabolic Syndrome
Other: Water
Other: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Mexican National Institute of Public Health:

Primary Outcome Measures:
  • Triglycerides blood level [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Triglycerides blood levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Triglycerides blood Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Triglycerides blood levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Homeostasis Model Assessment (HOMA) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Glycosylated (or glycated) hemoglobin (HbA1c) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Boby Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Homeostasis Model Assessment (HOMA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Homeostasis Model Assessment (HOMA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Homeostasis Model Assessment (HOMA) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Glycosylated (or glycated) hemoglobin (HbA1c) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: April 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Education
Other Name: Education only

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245010

Locations
Mexico
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

No publications provided

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
Study First Received: May 20, 2010
Last Updated: October 10, 2011
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Mexican National Institute of Public Health:
Metabolic Syndrome
Water
Obesity
Clinical trial
Prevention

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

ClinicalTrials.gov processed this record on July 20, 2014