Milk Proteins and Micronutrient Supplementation in Obese Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Dietary Supplement: Supplement with micronutrients
* Other: Nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with obesity (BMI>30) Aged: 6 to 11 years Both sex Parents accepted to participate and signed informant consent Exclusion Criteria: Children with dyslipidemia Metabolic disease Hypertension Physical disability Using vitamins and minerals supplements and/or receiving treatment for obesity during the last 3 months.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement with micronutrients<br>Nutrition education with a supplement | Dietary Supplement: Supplement with micronutrients<br>* 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.<br>|
| Experimental: Nutrition education<br>Group received only nutrition education | Other: Nutrition education<br>* Group received nutrition education program during 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body fat | change in fat | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Change in total cholesterol | Beaseline to 6 months | 
| HDL | change in HDL | Baseline to 6 months | 
| LDL | change in LDL | baseline to 6 months | 
| Triglycerides | change in triglycerides | baseline to 6 months | 
| Glucose | change in glucose | baseline to 6 months | 
| Interleukin 6 (IL-6) | Change in IL-6 | baseline to 6 months | 
| Interleukin 10 (IL-10) | change of IL-10 change in IL-10 | baseline to 6 months | 
| C reactive protein (CRP) | change of CRP | baseline to 6 months | 
| Bone mineral density (BMD) | change in BMD | baseline to 6 months | 
| Body mass index (BMI) | Change in BMI | Baseline to 6 months | 
| Zinc levels | Change in zinc levels | baseline to 6 months | 
| Iron levels | Change in iron levels | baseline to 6 months | 
| A vitamin levels | change in A vitamin levels | baseline to 6 months | 
| C vitamin levels | change of C vitamin levels | baseline to 6 months | 
| D vitamin levels | change in D vitamin levels | baseline to 6 months | 
| E vitamin levels | change of E vitamin levels | baseline to 6 months | 
| Systolic blood pressure (SBP) | change in SBP | baseline to 6 months | 
| Diastolic blood pressure (DBP) | change in (DBP) | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, micronutrients, school-age children, milk proteins