NCT04319419

Milk Proteins and Micronutrient Supplementation in Obese Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Universidad Autonoma de Queretaro · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Supplement with micronutrients	Obese children were divided in 2 groups. A group received the supplement plus nutrition education and other group was a control, only received nutrition education.
OTHER	Nutrition education	Group received nutrition education program during 6 months

Timeline

• Start date: 2011-12-05
• Primary completion: 2012-12-05
• Completion: 2012-12-05
• First posted: 2020-03-24
• Last updated: 2020-03-24