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

Tangier Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886482
• Other study ID #: high protein diet in childhood
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2013
• Last updated: June 25, 2013
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Mass Index Quantitative Trait Locus 7 Disorder
• Tangier Disease

Intervention

Other:
• nutrition intervention
high protein diet

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of weight reduction in two dietary groups	weight reduction (kg)	10 weeks	Yes
Secondary	LDL (mg/ml)		10 weeks	Yes
Secondary	HDL (mg/ml)		10 weeks	Yes
Secondary	fasting blood glucose		10 weeks	Yes
Secondary	total cholesterol (mg/dl)		10 weeks	Yes
Secondary	blood pressure		10 weeks	Yes