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

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ClinicalTrials.gov Identifier: NCT01886482
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : June 26, 2013
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : September 2012

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: nutrition intervention
high protein diet
 Other: nutrition intervention
high protein diet
No Intervention: no intervention
control diet


Outcome Measures
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Primary Outcome Measures :
  1. the amount of weight reduction in two dietary groups [ Time Frame: 10 weeks ]
    weight reduction (kg)


Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hypoalphalipoproteinemias
Tangier Disease
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hypolipoproteinemias
 Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases