Milk Proteins and Micronutrient Supplementation in Obese Children

Obesity, Childhood Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319419
• Other study ID #: FNN201104
• Status: Completed
• Phase: N/A
• Start date: December 5, 2011
• Est. completion date: December 5, 2012

Study information

• Verified date: March 2020
• Source: Universidad Autonoma de Queretaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 5, 2012
• Est. primary completion date: December 5, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

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.

Other:
• Nutrition education
Group received nutrition education program during 6 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro	NUCITEC S.A. de C.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body fat	change in fat	baseline to 6 months
Secondary	Total cholesterol	Change in total cholesterol	Beaseline to 6 months
Secondary	HDL	change in HDL	Baseline to 6 months
Secondary	LDL	change in LDL	baseline to 6 months
Secondary	Triglycerides	change in triglycerides	baseline to 6 months
Secondary	Glucose	change in glucose	baseline to 6 months
Secondary	Interleukin 6 (IL-6)	Change in IL-6	baseline to 6 months
Secondary	Interleukin 10 (IL-10)	change of IL-10 change in IL-10	baseline to 6 months
Secondary	C reactive protein (CRP)	change of CRP	baseline to 6 months
Secondary	Bone mineral density (BMD)	change in BMD	baseline to 6 months
Secondary	Body mass index (BMI)	Change in BMI	Baseline to 6 months
Secondary	Zinc levels	Change in zinc levels	baseline to 6 months
Secondary	Iron levels	Change in iron levels	baseline to 6 months
Secondary	A vitamin levels	change in A vitamin levels	baseline to 6 months
Secondary	C vitamin levels	change of C vitamin levels	baseline to 6 months
Secondary	D vitamin levels	change in D vitamin levels	baseline to 6 months
Secondary	E vitamin levels	change of E vitamin levels	baseline to 6 months
Secondary	Systolic blood pressure (SBP)	change in SBP	baseline to 6 months
Secondary	Diastolic blood pressure (DBP)	change in (DBP)	baseline to 6 months