Milk Proteins and Micronutrient Supplementation in Obese Children

NCT ID: NCT04319419

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-05
• Study Completion Date: 2012-12-05

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.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supplement with micronutrients

Nutrition education with a supplement

Group Type: EXPERIMENTAL

Supplement with micronutrients

Intervention Type: 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

Group received only nutrition education

Group Type: EXPERIMENTAL

Nutrition education

Intervention Type: OTHER

Group received nutrition education program during 6 months

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Nutrition education

Group received nutrition education program during 6 months

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NUCITEC S.A. de C.V.

UNKNOWN

Sponsor Role: collaborator

Universidad Autonoma de Queretaro

OTHER

Sponsor Role: lead

Responsible Party

Jorge Luis Rosado Loria

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FNN201104

Identifier Type: -

Identifier Source: org_study_id