Effectiveness of a Supplement Containning Milk Proteins, Vitamins and Minerals to Reduce Fat Deposition, Systemic Inflammation and Improve Nutritional Status in Obese School-age Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 主要终点
- Total body fat
研究概览
简要总结
Milk proteins and micronutrients could be beneficial in the prevention and treatment of obesity.
The objective was to evaluate a supplement with milk proteins and multivitamins and minerals with nutrition education on anthropometry, body composition, micronutrient status, blood pressure, lipid profile, systemic inflammation, leptin and insulin resistance in obese children at baseline and after 6 months.
详细描述
Obese children were selected in elementary schools from 5 rural communities of the State of Querétaro. One hundred fifty two obese children (Z-score >2 standard deviations) aged 6-11y were randomly assigned to receive one of two treatments: 1) 237mL/day of milk proteins and multiple micronutrients supplement (MPMS) plus Nutrition Education (NE) program or 2) NE alone for 24 weeks.
Children in both groups were evaluated at baseline and 6 months after treatment initiated. At both times the following variables were evaluated:
Visit 1 (Screening): Mothers and parents received oral and written information regarding all aspects of the study. Informed consent, medical history, demographic information, weight and height were obtained.
Visit 2 (Clinical Laboratory testing): A blood preasure and sample was taken by an specialist. Blood test included Glucose, total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol, Tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6) and interleukin-10 (IL-10), C reactive protein, insulin and leptin.
Visit 3 (Nutrition Clinic at UAQ): body composition was determined by DEXA. The NE were given at Nutrition Clinic and school to the children's parents each week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with obesity (BMI>30)
- •Aged: 6 to 11 years
- •Parents accepted to participate and signed informant consent
排除标准
- •Children with dyslipidemia
- •Metabolic disease
- •Hypertension
- •Physical disability
- •Using vitamins and minerals supplements and/or receiving treatment for obesity during the last 3 months.
结局指标
主要结局
Total body fat
时间窗: baseline to 6 months
change in fat
次要结局
- Total cholesterol(Beaseline to 6 months)
- Triglycerides(baseline to 6 months)
- Systolic blood pressure (SBP)(baseline to 6 months)
- HDL(Baseline to 6 months)
- C vitamin levels(baseline to 6 months)
- Diastolic blood pressure (DBP)(baseline to 6 months)
- LDL(baseline to 6 months)
- Interleukin 6 (IL-6)(baseline to 6 months)
- Interleukin 10 (IL-10)(baseline to 6 months)
- Bone mineral density (BMD)(baseline to 6 months)
- Iron levels(baseline to 6 months)
- A vitamin levels(baseline to 6 months)
- E vitamin levels(baseline to 6 months)
- Glucose(baseline to 6 months)
- C reactive protein (CRP)(baseline to 6 months)
- Body mass index (BMI)(Baseline to 6 months)
- Zinc levels(baseline to 6 months)
- D vitamin levels(baseline to 6 months)
研究者
Jorge Luis Rosado Loria
Principal Investigator
Universidad Autonoma de Queretaro