Milk Proteins and Micronutrient Supplementation in Obese Children
- Conditions
- Obesity, Childhood
- Interventions
- Dietary Supplement: Supplement with micronutrientsOther: Nutrition education
- Registration Number
- NCT04319419
- Lead Sponsor
- Universidad Autonoma de Queretaro
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- Children with obesity (BMI>30)
- Aged: 6 to 11 years
- Both sex
- Parents accepted to participate and signed informant consent
- Children with dyslipidemia
- Metabolic disease
- Hypertension
- Physical disability
- Using vitamins and minerals supplements and/or receiving treatment for obesity during the last 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supplement with micronutrients Supplement with micronutrients Nutrition education with a supplement Nutrition education Nutrition education Group received only nutrition education
- Primary Outcome Measures
Name Time Method Total body fat baseline to 6 months change in fat
- Secondary Outcome Measures
Name Time Method Total cholesterol Beaseline to 6 months Change in total cholesterol
Triglycerides baseline to 6 months change in triglycerides
Systolic blood pressure (SBP) baseline to 6 months change in SBP
HDL Baseline to 6 months change in HDL
C vitamin levels baseline to 6 months change of C vitamin levels
LDL baseline to 6 months change in LDL
Interleukin 6 (IL-6) baseline to 6 months Change in IL-6
Interleukin 10 (IL-10) baseline to 6 months change of IL-10 change in IL-10
Bone mineral density (BMD) baseline to 6 months change in BMD
Iron levels baseline to 6 months Change in iron levels
A vitamin levels baseline to 6 months change in A vitamin levels
E vitamin levels baseline to 6 months change of E vitamin levels
Glucose baseline to 6 months change in glucose
C reactive protein (CRP) baseline to 6 months change of CRP
Body mass index (BMI) Baseline to 6 months Change in BMI
Zinc levels baseline to 6 months Change in zinc levels
D vitamin levels baseline to 6 months change in D vitamin levels
Diastolic blood pressure (DBP) baseline to 6 months change in (DBP)