Skip to main content
OpenTrials
Completed

NCT Number: NCT04319419

Milk Proteins and Micronutrient Supplementation in Obese Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplement with micronutrients

Dietary Supplement

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.

Nutrition education

Other

Group received nutrition education program during 6 months

Primary outcomes

  1. Total body fat

    Time frame: baseline to 6 months

    change in fat

Secondary outcomes

  1. Total cholesterol

    Time frame: Beaseline to 6 months

    Change in total cholesterol

  2. HDL

    Time frame: Baseline to 6 months

    change in HDL

  3. LDL

    Time frame: baseline to 6 months

    change in LDL

  4. Triglycerides

    Time frame: baseline to 6 months

    change in triglycerides

  5. Glucose

    Time frame: baseline to 6 months

    change in glucose

  6. Interleukin 6 (IL-6)

    Time frame: baseline to 6 months

    Change in IL-6

  7. Interleukin 10 (IL-10)

    Time frame: baseline to 6 months

    change of IL-10 change in IL-10

  8. C reactive protein (CRP)

    Time frame: baseline to 6 months

    change of CRP

  9. Bone mineral density (BMD)

    Time frame: baseline to 6 months

    change in BMD

  10. Body mass index (BMI)

    Time frame: Baseline to 6 months

    Change in BMI

  11. Zinc levels

    Time frame: baseline to 6 months

    Change in zinc levels

  12. Iron levels

    Time frame: baseline to 6 months

    Change in iron levels

  13. A vitamin levels

    Time frame: baseline to 6 months

    change in A vitamin levels

  14. C vitamin levels

    Time frame: baseline to 6 months

    change of C vitamin levels

  15. D vitamin levels

    Time frame: baseline to 6 months

    change in D vitamin levels

  16. E vitamin levels

    Time frame: baseline to 6 months

    change of E vitamin levels

  17. Systolic blood pressure (SBP)

    Time frame: baseline to 6 months

    change in SBP

  18. Diastolic blood pressure (DBP)

    Time frame: baseline to 6 months

    change in (DBP)

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Queretaro

Other

Collaborators

  • NUCITEC S.A. de C.V.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 24, 2020
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.