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Completed

NCT Number: NCT01886482

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.

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Key information

Conditions

Body Mass Index Quantitative Trait Locus 7 Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypoalphalipoproteinemias Hypolipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Polyneuropathies Tangier Disease

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Isfahan University of Medical Sciences

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Intervention

Other

high protein diet

Primary outcomes

  1. the amount of weight reduction in two dietary groups

    Time frame: 10 weeks

    weight reduction (kg)

Secondary outcomes

  1. LDL (mg/ml)

    Time frame: 10 weeks

  2. HDL (mg/ml)

    Time frame: 10 weeks

  3. fasting blood glucose

    Time frame: 10 weeks

  4. total cholesterol (mg/dl)

    Time frame: 10 weeks

  5. blood pressure

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 26, 2013
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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