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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
  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:


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:
Hypolipoproteinemias
Cardiovascular Diseases
Tangier Disease
Dyslipidemias
Genetic Diseases, Inborn
Hypoalphalipoproteinemias
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 November 20, 2014