Back to resultsEffect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children
Primary Purpose
Body Mass Index Quantitative Trait Locus 5 Disorder, Tangier Disease
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
nutrition intervention
Sponsored by
About this trial
This is an interventional health services research trial for Body Mass Index Quantitative Trait Locus 5 Disorder
Eligibility 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
Sites / Locations
- Isfahan University of Medical Sciences Leila Azadbakht, Phd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
nutrition intervention
control diet
Arm Description
high protein diet
Outcomes
Primary Outcome Measures
adiponectin (mcg/ml)
amount of adiponectin
Secondary Outcome Measures
interlukine 6 (mcg/ml)
tumor necrosis factor alpha (ng/ml)
C reactive protein (mcg/ml)
fibrinogen (mcg/ml)
Full Information
NCT ID
NCT01886495
First Posted
June 21, 2013
Last Updated
June 25, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01886495
Brief Title
Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children
Official Title
High Protein Diet , Adiponectin and Inflammatory Factors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Mass Index Quantitative Trait Locus 5 Disorder, Tangier Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nutrition intervention
Arm Type
Active Comparator
Arm Description
high protein diet
Arm Title
control diet
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
nutrition intervention
Other Intervention Name(s)
high protein diet
Primary Outcome Measure Information:
Title
adiponectin (mcg/ml)
Description
amount of adiponectin
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
interlukine 6 (mcg/ml)
Time Frame
10 weeks
Title
tumor necrosis factor alpha (ng/ml)
Time Frame
10 weeks
Title
C reactive protein (mcg/ml)
Time Frame
10 weeks
Title
fibrinogen (mcg/ml)
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Azadbakht, PhD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isfahan University of Medical Sciences Leila Azadbakht, Phd
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children
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