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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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

Detailed Summary:

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.


Sponsor: Isfahan University of Medical Sciences

Current Primary Outcome: the amount of weight reduction in two dietary groups [ Time Frame: 10 weeks ]

weight reduction (kg)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • LDL (mg/ml) [ Time Frame: 10 weeks ]
  • HDL (mg/ml) [ Time Frame: 10 weeks ]
  • fasting blood glucose [ Time Frame: 10 weeks ]
  • total cholesterol (mg/dl) [ Time Frame: 10 weeks ]
  • blood pressure [ Time Frame: 10 weeks ]


Original Secondary Outcome: Same as current

Information By: Isfahan University of Medical Sciences

Dates:
Date Received: June 21, 2013
Date Started: September 2011
Date Completion:
Last Updated: June 25, 2013
Last Verified: June 2013