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

NCT ID: NCT01886482

Last Updated: 2013-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Body Mass Index Quantitative Trait Locus 7 Disorder Tangier Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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nutrition intervention

high protein diet

Group Type ACTIVE_COMPARATOR

nutrition intervention

Intervention Type OTHER

high protein diet

no intervention

control diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nutrition intervention

high protein diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Azadbakht

Isfahan University of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isfahan University of Medical Sciences

Isfahan, , Iran

Site Status

Countries

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Iran

Other Identifiers

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high protein diet in childhood

Identifier Type: -

Identifier Source: org_study_id

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