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Milk Proteins and Micronutrient Supplementation in Obese Children

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supplement with micronutrients
Nutrition education
Sponsored by
Universidad Autonoma de Queretaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring micronutrients, obesity, school-age children, milk proteins

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Supplement with micronutrients

    Nutrition education

    Arm Description

    Nutrition education with a supplement

    Group received only nutrition education

    Outcomes

    Primary Outcome Measures

    Total body fat
    change in fat

    Secondary Outcome Measures

    Total cholesterol
    Change in total cholesterol
    HDL
    change in HDL
    LDL
    change in LDL
    Triglycerides
    change in triglycerides
    Glucose
    change in glucose
    Interleukin 6 (IL-6)
    Change in IL-6
    Interleukin 10 (IL-10)
    change of IL-10 change in IL-10
    C reactive protein (CRP)
    change of CRP
    Bone mineral density (BMD)
    change in BMD
    Body mass index (BMI)
    Change in BMI
    Zinc levels
    Change in zinc levels
    Iron levels
    Change in iron levels
    A vitamin levels
    change in A vitamin levels
    C vitamin levels
    change of C vitamin levels
    D vitamin levels
    change in D vitamin levels
    E vitamin levels
    change of E vitamin levels
    Systolic blood pressure (SBP)
    change in SBP
    Diastolic blood pressure (DBP)
    change in (DBP)

    Full Information

    First Posted
    February 28, 2020
    Last Updated
    March 23, 2020
    Sponsor
    Universidad Autonoma de Queretaro
    Collaborators
    NUCITEC S.A. de C.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04319419
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 5, 2011 (Actual)
    Primary Completion Date
    December 5, 2012 (Actual)
    Study Completion Date
    December 5, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de Queretaro
    Collaborators
    NUCITEC S.A. de C.V.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood
    Keywords
    micronutrients, obesity, school-age children, milk proteins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    152 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supplement with micronutrients
    Arm Type
    Experimental
    Arm Description
    Nutrition education with a supplement
    Arm Title
    Nutrition education
    Arm Type
    Experimental
    Arm Description
    Group received only nutrition education
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Supplement with micronutrients
    Intervention Description
    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
    Other
    Intervention Name(s)
    Nutrition education
    Intervention Description
    Group received nutrition education program during 6 months
    Primary Outcome Measure Information:
    Title
    Total body fat
    Description
    change in fat
    Time Frame
    baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    Total cholesterol
    Description
    Change in total cholesterol
    Time Frame
    Beaseline to 6 months
    Title
    HDL
    Description
    change in HDL
    Time Frame
    Baseline to 6 months
    Title
    LDL
    Description
    change in LDL
    Time Frame
    baseline to 6 months
    Title
    Triglycerides
    Description
    change in triglycerides
    Time Frame
    baseline to 6 months
    Title
    Glucose
    Description
    change in glucose
    Time Frame
    baseline to 6 months
    Title
    Interleukin 6 (IL-6)
    Description
    Change in IL-6
    Time Frame
    baseline to 6 months
    Title
    Interleukin 10 (IL-10)
    Description
    change of IL-10 change in IL-10
    Time Frame
    baseline to 6 months
    Title
    C reactive protein (CRP)
    Description
    change of CRP
    Time Frame
    baseline to 6 months
    Title
    Bone mineral density (BMD)
    Description
    change in BMD
    Time Frame
    baseline to 6 months
    Title
    Body mass index (BMI)
    Description
    Change in BMI
    Time Frame
    Baseline to 6 months
    Title
    Zinc levels
    Description
    Change in zinc levels
    Time Frame
    baseline to 6 months
    Title
    Iron levels
    Description
    Change in iron levels
    Time Frame
    baseline to 6 months
    Title
    A vitamin levels
    Description
    change in A vitamin levels
    Time Frame
    baseline to 6 months
    Title
    C vitamin levels
    Description
    change of C vitamin levels
    Time Frame
    baseline to 6 months
    Title
    D vitamin levels
    Description
    change in D vitamin levels
    Time Frame
    baseline to 6 months
    Title
    E vitamin levels
    Description
    change of E vitamin levels
    Time Frame
    baseline to 6 months
    Title
    Systolic blood pressure (SBP)
    Description
    change in SBP
    Time Frame
    baseline to 6 months
    Title
    Diastolic blood pressure (DBP)
    Description
    change in (DBP)
    Time Frame
    baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

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