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Milk Proteins and Micronutrient Supplementation in Obese Children

U

Universidad Autonoma de Queretaro

Status

Completed

Conditions

Obesity, Childhood

Treatments

Other: Nutrition education
Dietary Supplement: Supplement with micronutrients

Study type

Interventional

Funder types

Other

Identifiers

NCT04319419
FNN201104

Details and patient eligibility

About

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.

Full 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.

Enrollment

152 patients

Sex

All

Ages

6 to 11 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

152 participants in 2 patient groups

Supplement with micronutrients
Experimental group
Description:
Nutrition education with a supplement
Treatment:
Dietary Supplement: Supplement with micronutrients
Nutrition education
Experimental group
Description:
Group received only nutrition education
Treatment:
Other: Nutrition education

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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