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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Leila Azadbakht, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01886482

First received: June 21, 2013

Last updated: June 25, 2013

Last verified: June 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Body Mass Index Quantitative Trait Locus 7 Disorder Tangier Disease	Other: nutrition intervention	Phase 3


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

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease familial HDL deficiency Tangier disease

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease Hypolipoproteinemia Sphingolipidosis Tangier Disease

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:

the amount of weight reduction in two dietary groups [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
weight reduction (kg)

Secondary Outcome Measures:

LDL (mg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
HDL (mg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
fasting blood glucose [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
total cholesterol (mg/dl) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
blood pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	50
Study Start Date:	September 2011
Study Completion Date:	September 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: nutrition intervention high protein diet	Other: nutrition intervention high protein diet
No Intervention: no intervention control diet

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.

Eligibility


Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886482

Locations


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

Sponsors and Collaborators

Isfahan University of Medical Sciences

More Information

No publications provided


Responsible Party:	Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01886482 History of Changes
Other Study ID Numbers:	high protein diet in childhood
Study First Received:	June 21, 2013
Last Updated:	June 25, 2013
Health Authority:	Iran: Ethics Committee

Additional relevant MeSH terms:


Hypoalphalipoproteinemias Cardiovascular Diseases Tangier Disease Dyslipidemias Genetic Diseases, Inborn Hypolipoproteinemias Lipid Metabolism Disorders	Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

ClinicalTrials.gov processed this record on February 26, 2015

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