Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
Primary Purpose
Body Mass Index Quantitative Trait Locus 7 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 7 Disorder
Eligibility 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
Sites / Locations
- Isfahan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
nutrition intervention
no intervention
Arm Description
high protein diet
control diet
Outcomes
Primary Outcome Measures
the amount of weight reduction in two dietary groups
weight reduction (kg)
Secondary Outcome Measures
LDL (mg/ml)
HDL (mg/ml)
fasting blood glucose
total cholesterol (mg/dl)
blood pressure
Full Information
NCT ID
NCT01886482
First Posted
June 21, 2013
Last Updated
June 25, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01886482
Brief Title
Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
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 CVD risk factors among overweight and obese children.
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.
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 7 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
no intervention
Arm Type
No Intervention
Arm Description
control diet
Intervention Type
Other
Intervention Name(s)
nutrition intervention
Intervention Description
high protein diet
Primary Outcome Measure Information:
Title
the amount of weight reduction in two dietary groups
Description
weight reduction (kg)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
LDL (mg/ml)
Time Frame
10 weeks
Title
HDL (mg/ml)
Time Frame
10 weeks
Title
fasting blood glucose
Time Frame
10 weeks
Title
total cholesterol (mg/dl)
Time Frame
10 weeks
Title
blood pressure
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
no taken medications
Exclusion Criteria:
do not prescribe their diet
mental retardation
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
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