Skip to main content
Clinical Trials/NCT01886482
NCT01886482
Completed
Phase 3

Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children

Isfahan University of Medical Sciences1 site in 1 country50 target enrollmentSeptember 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Body Mass Index Quantitative Trait Locus 7 Disorder
Sponsor
Isfahan University of Medical Sciences
Enrollment
50
Locations
1
Primary Endpoint
the amount of weight reduction in two dietary groups
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Detailed Description

Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results. Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children. Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
September 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leila Azadbakht

Isfahan University of Medical Sciences

Isfahan University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • BMI \> 85th age of 6-11 years
  • no history of chronic diseases
  • no taken medications

Exclusion Criteria

  • do not prescribe their diet
  • mental retardation

Outcomes

Primary Outcomes

the amount of weight reduction in two dietary groups

Time Frame: 10 weeks

weight reduction (kg)

Secondary Outcomes

  • LDL (mg/ml)(10 weeks)
  • HDL (mg/ml)(10 weeks)
  • fasting blood glucose(10 weeks)
  • total cholesterol (mg/dl)(10 weeks)
  • blood pressure(10 weeks)

Study Sites (1)

Loading locations...

Similar Trials