Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women
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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 |
- 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 ]
- 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 |
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
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 May 23, 2013