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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04319419
Enrollment
152
Registered
2020-03-24
Start date
2011-12-05
Completion date
2012-12-05
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

micronutrients, obesity, school-age children, milk proteins

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.

Interventions

DIETARY_SUPPLEMENTSupplement 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.

OTHERNutrition education

Group received nutrition education program during 6 months

Sponsors

NUCITEC S.A. de C.V.
CollaboratorUNKNOWN
Universidad Autonoma de Queretaro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total body fatbaseline to 6 monthschange in fat

Secondary

MeasureTime frameDescription
HDLBaseline to 6 monthschange in HDL
LDLbaseline to 6 monthschange in LDL
Triglyceridesbaseline to 6 monthschange in triglycerides
Glucosebaseline to 6 monthschange in glucose
Interleukin 6 (IL-6)baseline to 6 monthsChange in IL-6
Interleukin 10 (IL-10)baseline to 6 monthschange of IL-10 change in IL-10
C reactive protein (CRP)baseline to 6 monthschange of CRP
Bone mineral density (BMD)baseline to 6 monthschange in BMD
Total cholesterolBeaseline to 6 monthsChange in total cholesterol
Zinc levelsbaseline to 6 monthsChange in zinc levels
Iron levelsbaseline to 6 monthsChange in iron levels
A vitamin levelsbaseline to 6 monthschange in A vitamin levels
C vitamin levelsbaseline to 6 monthschange of C vitamin levels
D vitamin levelsbaseline to 6 monthschange in D vitamin levels
E vitamin levelsbaseline to 6 monthschange of E vitamin levels
Systolic blood pressure (SBP)baseline to 6 monthschange in SBP
Diastolic blood pressure (DBP)baseline to 6 monthschange in (DBP)
Body mass index (BMI)Baseline to 6 monthsChange in BMI

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026