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

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

Study Overview

• Status: Completed
• Conditions: Tangier Disease; Body Mass Index Quantitative Trait Locus 7 Disorder
• Intervention / Treatment: Other: nutrition intervention

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Isfahan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nutrition intervention; high protein diet	Other: nutrition intervention; high protein diet
No Intervention: no intervention; control diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the amount of weight reduction in two dietary groups	weight reduction (kg)	10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 26, 2013

Study Record Updates

• Last Update Posted (Estimate): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Neuromuscular Diseases; Peripheral Nervous System Diseases; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Polyneuropathies; Hypolipoproteinemias; Hypoalphalipoproteinemias; Tangier Disease
• Other Study ID Numbers: high protein diet in childhood