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

Phase 3

Completed

• Conditions: Body Mass Index Quantitative Trait Locus 7 Disorder; Tangier Disease
• Interventions: Other: nutrition intervention

• Registration Number: NCT01886482
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2012-09
• Status Verified: 2013-06
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-25
• Last Update Submitted: 2013-06-25
• Study First Posted: 2013-06-26
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutrition intervention	nutrition intervention	high protein diet

Primary Outcome Measures

Name	Time	Method
the amount of weight reduction in two dietary groups	10 weeks	weight reduction (kg)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of