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

I

Isfahan University of Medical Sciences

Status and phase

Completed
Phase 3

Conditions

Body Mass Index Quantitative Trait Locus 7 Disorder
Tangier Disease

Treatments

Other: nutrition intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01886482
high protein diet in childhood

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

6 to 11 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

nutrition intervention
Active Comparator group
Description:
high protein diet
Treatment:
Other: nutrition intervention
no intervention
No Intervention group
Description:
control diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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