Clinical trial NCT04319419: Milk Proteins and Micronutrient Supplementation in Obese Children
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: micronutrients
obesity
school-age children
milk proteins
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
Collaborators: name: NUCITEC S.A. de C.V.
First posted: 2020-03-24
Enrollment: 152
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total body fat
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Total cholesterol
timeFrame: Beaseline to 6 months
measure: HDL
timeFrame: Baseline to 6 months
measure: LDL
timeFrame: baseline to 6 months
measure: Triglycerides
timeFrame: baseline to 6 months
measure: Glucose
timeFrame: baseline to 6 months
measure: Interleukin 6 (IL-6)
timeFrame: baseline to 6 months
measure: Interleukin 10 (IL-10)
timeFrame: baseline to 6 months
measure: C reactive protein (CRP)
timeFrame: baseline to 6 months
measure: Bone mineral density (BMD)
timeFrame: baseline to 6 months
measure: Body mass index (BMI)
timeFrame: Baseline to 6 months
measure: Zinc levels
timeFrame: baseline to 6 months
measure: Iron levels
timeFrame: baseline to 6 months
measure: A vitamin levels
timeFrame: baseline to 6 months
measure: C vitamin levels
timeFrame: baseline to 6 months
measure: D vitamin levels
timeFrame: baseline to 6 months
measure: E vitamin levels
timeFrame: baseline to 6 months
measure: Systolic blood pressure (SBP)
timeFrame: baseline to 6 months
measure: Diastolic blood pressure (DBP)
timeFrame: baseline to 6 months
Other outcomes:
Locations:
Study officials:
References: