Effect of High Protein Diet on Adiponectin and Inflammation 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:
NCT01886495
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 adiponectin and inflammatory factors among overweight and obese children.


Condition Intervention Phase
Body Mass Index Quantitative Trait Locus 5 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
Official Title: High Protein Diet , Adiponectin and Inflammatory Factors

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • adiponectin (mcg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    amount of adiponectin


Secondary Outcome Measures:
  • interlukine 6 (mcg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • tumor necrosis factor alpha (ng/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • C reactive protein (mcg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • fibrinogen (mcg/ml) [ 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
Other Name: high protein diet
No Intervention: control diet

  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
  • 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: 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
  More Information

No publications provided

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
Study First Received: June 21, 2013
Last Updated: June 25, 2013
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Tangier Disease
Dyslipidemias
Genetic Diseases, Inborn
Hypoalphalipoproteinemias
Hypolipoproteinemias
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 October 23, 2014