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Milk Proteins and Micronutrient Supplementation in Obese Children

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ClinicalTrials.gov Identifier: NCT04319419
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
NUCITEC S.A. de C.V.
Information provided by (Responsible Party):
Jorge Luis Rosado Loria, Universidad Autonoma de Queretaro

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.


Condition or disease Intervention/treatment Phase
Obesity, Childhood Dietary Supplement: Supplement with micronutrients Other: Nutrition education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : December 5, 2011
Actual Primary Completion Date : December 5, 2012
Actual Study Completion Date : December 5, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supplement with micronutrients
Nutrition education with a supplement
Dietary Supplement: Supplement 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.

Experimental: Nutrition education
Group received only nutrition education
Other: Nutrition education
Group received nutrition education program during 6 months




Primary Outcome Measures :
  1. Total body fat [ Time Frame: baseline to 6 months ]
    change in fat


Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: Beaseline to 6 months ]
    Change in total cholesterol

  2. HDL [ Time Frame: Baseline to 6 months ]
    change in HDL

  3. LDL [ Time Frame: baseline to 6 months ]
    change in LDL

  4. Triglycerides [ Time Frame: baseline to 6 months ]
    change in triglycerides

  5. Glucose [ Time Frame: baseline to 6 months ]
    change in glucose

  6. Interleukin 6 (IL-6) [ Time Frame: baseline to 6 months ]
    Change in IL-6

  7. Interleukin 10 (IL-10) [ Time Frame: baseline to 6 months ]
    change of IL-10 change in IL-10

  8. C reactive protein (CRP) [ Time Frame: baseline to 6 months ]
    change of CRP

  9. Bone mineral density (BMD) [ Time Frame: baseline to 6 months ]
    change in BMD

  10. Body mass index (BMI) [ Time Frame: Baseline to 6 months ]
    Change in BMI

  11. Zinc levels [ Time Frame: baseline to 6 months ]
    Change in zinc levels

  12. Iron levels [ Time Frame: baseline to 6 months ]
    Change in iron levels

  13. A vitamin levels [ Time Frame: baseline to 6 months ]
    change in A vitamin levels

  14. C vitamin levels [ Time Frame: baseline to 6 months ]
    change of C vitamin levels

  15. D vitamin levels [ Time Frame: baseline to 6 months ]
    change in D vitamin levels

  16. E vitamin levels [ Time Frame: baseline to 6 months ]
    change of E vitamin levels

  17. Systolic blood pressure (SBP) [ Time Frame: baseline to 6 months ]
    change in SBP

  18. Diastolic blood pressure (DBP) [ Time Frame: baseline to 6 months ]
    change in (DBP)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Jorge Luis Rosado Loria, Principal Investigator, Universidad Autonoma de Queretaro
ClinicalTrials.gov Identifier: NCT04319419    
Other Study ID Numbers: FNN201104
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jorge Luis Rosado Loria, Universidad Autonoma de Queretaro:
micronutrients
obesity
school-age children
milk proteins
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs