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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Dietary supplement: Supplement with micronutrients; Other: Nutrition education

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplement with micronutrients; Nutrition education with a supplement	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.
Experimental: Nutrition education; Group received only nutrition education	Other: Nutrition education; Group received nutrition education program during 6 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Autónoma de Querétaro
• Collaborators: NUCITEC S.A. de C.V.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2011
• Primary Completion (Actual): December 5, 2012
• Study Completion (Actual): December 5, 2012

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: obesity; micronutrients; school-age children; milk proteins
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: FNN201104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No