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Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children

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ClinicalTrials.gov Identifier: NCT01886495
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

Brief Summary:
The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.

Condition or disease Intervention/treatment Phase
Body Mass Index Quantitative Trait Locus 5 Disorder Tangier Disease Other: nutrition intervention Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: High Protein Diet , Adiponectin and Inflammatory Factors
Study Start Date : September 2011
Primary Completion Date : December 2011
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. adiponectin (mcg/ml) [ Time Frame: 10 weeks ]
    amount of adiponectin


Secondary Outcome Measures :
  1. interlukine 6 (mcg/ml) [ Time Frame: 10 weeks ]
  2. tumor necrosis factor alpha (ng/ml) [ Time Frame: 10 weeks ]
  3. C reactive protein (mcg/ml) [ Time Frame: 10 weeks ]
  4. fibrinogen (mcg/ml) [ Time Frame: 10 weeks ]


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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
  • taken medications

Exclusion Criteria:

  • do not prescribe their diet
  • mental retardation

Information from the National Library of Medicine

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): NCT01886495


Locations
Iran, Islamic Republic of
Isfahan University of Medical Sciences Leila Azadbakht, Phd
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences

Responsible Party: Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01886495     History of Changes
Other Study ID Numbers: high protein diet in children
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

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