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
About this trial
This is an interventional treatment trial for Obesity, Childhood focused on measuring micronutrients, obesity, school-age children, milk proteins
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.
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
NCT ID
NCT04319419
First Posted
February 28, 2020
Last Updated
March 23, 2020
Sponsor
Universidad Autonoma de Queretaro
Collaborators
NUCITEC S.A. de C.V.
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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Milk Proteins and Micronutrient Supplementation in Obese Children
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