Randomized Controlled Trial of a Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Triglycerides blood level
研究概览
简要总结
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
详细描述
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 250 calories per day from caloric beverages (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic beverages). It is important to note that this is the average intake from caloric beverages for Mexican adolescent and adult women and represents the average Mexican adolescent and young woman behavior
Recruitment Participants will be recruited at a private weight-reduction clinic in Cuernavaca, Morelos (study site). Women will be invited to participate through local advertisements. Potential participants will be screened in order to evaluate if they fulfill the selection criteria of caloric beverages, BMI and triglyceride levels. Subsequently, in order to identify women with a high sweetened-beverage consumption women selected during the fist screening will be followed during a one-month period (referred to as the screening stage from now on), prior to recruitment into the intervention.
Screening stage This stage will consist in one month period of follow-up of women who have fulfilled the BMI, age, triglyceride and other selection criteria. During this period, three simplified 24-hr beverage-oriented dietary recalls (2 during week days and one weekend) will be collected approximately 7-10 days apart from each other. These 24 hr-recalls will exclusively seek to evaluate high caloric intake coming from sweetened caloric beverages. Specifically, the investigators will evaluate the consumption of all commercial and homemade caloric sweetened beverages (including juices, "aguas frescas", coffee and tea with added sugar). The investigators will also measure triglyceride levels in a blood drop collected through finger prick, at the study site. The specimen collection process will be quick, and with minimal discomfort for the participants. The investigators will use special lancet and a couple of drops of blood will be taken from a nick of a finger and deposited onto special analytic strip. Finally, a pregnancy test will be performed at the first visit for confirmation purposes.
Upon conclusion of the screening stage eligible participants will be randomly assigned to either the intervention or control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Triglycerides blood level
时间窗: baseline
Triglycerides blood levels
时间窗: 9 months
Triglycerides blood Levels
时间窗: 6 months
次要结局
- Body weight(9 months)
- Fasting insulin(9 months)
- Fasting glucose(9 months)
- Homeostasis Model Assessment (HOMA)(9 months)
- HDL-cholesterol(9 months)
- Systolic and diastolic blood pressure(9 months)
- Waist circumference(9 months)
- Glycosylated (or glycated) hemoglobin (HbA1c)(9 months)
- Boby Weight(3 months)
研究者
Sonia Hernandez-Cordero
Head of the Deparment of Community Nutrition
Mexican National Institute of Public Health