Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE June 26, 2013
Last Update Posted Date June 26, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
adiponectin (mcg/ml) [ Time Frame: 10 weeks ]
amount of adiponectin
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • interlukine 6 (mcg/ml) [ Time Frame: 10 weeks ]
  • tumor necrosis factor alpha (ng/ml) [ Time Frame: 10 weeks ]
  • C reactive protein (mcg/ml) [ Time Frame: 10 weeks ]
  • fibrinogen (mcg/ml) [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children
Official Title  ICMJE High Protein Diet , Adiponectin and Inflammatory Factors
Brief Summary The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Body Mass Index Quantitative Trait Locus 5 Disorder
  • Tangier Disease
Intervention  ICMJE Other: nutrition intervention
Other Name: high protein diet
Study Arms  ICMJE
  • Active Comparator: nutrition intervention
    high protein diet
    Intervention: Other: nutrition intervention
  • No Intervention: control diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01886495
Other Study ID Numbers  ICMJE high protein diet in children
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leila Azadbakht, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences
PRS Account Isfahan University of Medical Sciences
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP