The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment
研究概览
简要总结
The purpose of this study is to determine if a low fructose intake could have an impact on weight loss, uric acid levels and the components of the metabolic syndrome (glucose, cholesterol, triglycerides, insulin resistance, high blood pressure).
详细描述
Overweight and obesity are now considered a growing public health problem in Mexico and worldwide. This epidemic has been attributed to dietary fructose consumption. Although experimental models have demonstrated a role of fructose in the development of obesity, metabolic syndrome and kidney disease, data in human models is lacking. The purpose of this study is to determine if a low fructose intake could have an impact on the components of the metabolic syndrome. The primary endpoint will be to determine the impact of low fructose on weight loss. Secondary endpoints will evaluate the impact of low fructose diet on blood pressure and cardiovascular biochemical profile.
If fructose is a causal pathway to obesity and metabolic syndrome, it may represent an important target to mitigate this important health problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a Body Mass Index (BMI) >
- •BMI defined as: Weight in kilograms divided by Height (squared) in meters.
- •Residents of Mexico city
- •Healthy individuals (no comorbidities or drug prescription for associated chronic diseases)
排除标准
- •Diabetes Mellitus Type 1 or 2
- •Severe Hypertension (defined as systolic blood pressure > 160 mmHg and /or diastolic blood pressure > 100 mmHg) and/or Hypertension on pharmacological treatment.
- •Chronic Kidney Disease (Glomerular Filtration Rate (GFR) < 60 ml/min)
- •Hepatic Damage or Advanced Disease (clinical, biochemical or histological)
- •Patient receiving any pharmacological treatments for hypercholesterolemia and/or elevated triglycerides.
- •Anemia (any etiology)
- •Malignancy
- •Pregnancy
结局指标
主要结局
Somatometry: including weight, height, Body Mass Index (BMI), % Body fat levels, waist and hip index, and blood pressure levels measurements performed by a single evaluator and calibrated equipment
时间窗: results obtained at the same day of evaluation (weekly monitoring during 6 weeks for each patient)
measurements will be performed by a trained evaluator
次要结局
- Blood samples: to evaluate metabolic syndrome parameters(basal and final (6 weeks interval between the basal and final results, for each patient))