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

NCT01245010 | Completed DMC

• 2 other identifiers: 755CINYS 812
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Water; Obesity; Clinical trial; Prevention

Outcome Measures

Primary Outcomes (4)

• Triglycerides blood level

  baseline

• Triglycerides blood levels

  3 months

• Triglycerides blood Levels

  6 months

• Triglycerides blood levels

  9 months

Secondary Outcomes (30)

• Body weight

  Baseline

• Fasting insulin

  Baseline

• Fasting glucose

  Baseline

• Homeostasis Model Assessment (HOMA)

  Baseline

• HDL-cholesterol

  Baseline

Study Arms (2)

Water

EXPERIMENTAL

Water and education provision

Other: Water

Control

ACTIVE COMPARATOR

Education only

Other: Education

Interventions

Water OTHER

Water and education will be provided

Also known as: Water and education

Water

Education OTHER

Education

Also known as: Education only

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mexican National Institute of Public Health: lead
• University of North Carolina, Chapel Hill: collaborator
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

Related Publications (2)

• Rodriguez-Ramirez S, Gonzalez de Cosio T, Mendez MA, Tucker KL, Mendez-Ramirez I, Hernandez-Cordero S, Popkin BM. A Water and Education Provision Intervention Modifies the Diet in Overweight Mexican Women in a Randomized Controlled Trial. J Nutr. 2015 Aug;145(8):1892-9. doi: 10.3945/jn.115.212852. Epub 2015 Jul 1.

  PMID: 26136584 DERIVED

• Hernandez-Cordero S, Barquera S, Rodriguez-Ramirez S, Villanueva-Borbolla MA, Gonzalez de Cossio T, Dommarco JR, Popkin B. Substituting water for sugar-sweetened beverages reduces circulating triglycerides and the prevalence of metabolic syndrome in obese but not in overweight Mexican women in a randomized controlled trial. J Nutr. 2014 Nov;144(11):1742-52. doi: 10.3945/jn.114.193490. Epub 2014 Sep 3.

  PMID: 25332472 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Interventions

Water; Educational Status

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Deparment of Community Nutrition

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: November 22, 2010
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

ME (1)