Milk Proteins and Micronutrient Supplementation in Obese Children

NCT04319419 | Completed DMC

• 1 other identifier: FNN201104
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity, Childhood

Keywords

micronutrients; obesity; school-age children; milk proteins

Outcome Measures

Primary Outcomes (1)

• Total body fat

  change in fat

  baseline to 6 months

Secondary Outcomes (18)

• Total cholesterol

  Beaseline to 6 months

• HDL

  Baseline to 6 months

• LDL

  baseline to 6 months

• Triglycerides

  baseline to 6 months

• Glucose

  baseline to 6 months

Study Arms (2)

Supplement with micronutrients

EXPERIMENTAL

Nutrition education with a supplement

Dietary Supplement: Supplement with micronutrients

Nutrition education

EXPERIMENTAL

Group received only nutrition education

Other: Nutrition education

Interventions

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.

Supplement with micronutrients

Nutrition education OTHER

Group received nutrition education program during 6 months

Nutrition education

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with obesity (BMI\>30)
• Aged: 6 to 11 years
• Both sex
• Parents accepted to participate and signed informant consent

You may not qualify if:

• Children with dyslipidemia
• Metabolic disease
• Hypertension
• Physical disability
• Using vitamins and minerals supplements and/or receiving treatment for obesity during the last 3 months.

Sponsors & Collaborators

• Universidad Autonoma de Queretaro: lead
• NUCITEC S.A. de C.V.: collaborator

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Micronutrients; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 24, 2020
• Study Start: December 5, 2011
• Primary Completion: December 5, 2012
• Study Completion: December 5, 2012
• Last Updated: March 24, 2020

Record last verified: 2020-03