Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
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ClinicalTrials.gov Identifier: NCT01886482 |
Recruitment Status
:
Completed
First Posted
: June 26, 2013
Last Update Posted
: June 26, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Body Mass Index Quantitative Trait Locus 7 Disorder Tangier Disease | Other: nutrition intervention | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: nutrition intervention
high protein diet
|
Other: nutrition intervention
high protein diet
|
No Intervention: no intervention
control diet
|
- the amount of weight reduction in two dietary groups [ Time Frame: 10 weeks ]weight reduction (kg)
- LDL (mg/ml) [ Time Frame: 10 weeks ]
- HDL (mg/ml) [ Time Frame: 10 weeks ]
- fasting blood glucose [ Time Frame: 10 weeks ]
- total cholesterol (mg/dl) [ Time Frame: 10 weeks ]
- blood pressure [ 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 |
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

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): NCT01886482
Iran, Islamic Republic of | |
Isfahan University of Medical Sciences | |
Isfahan, Iran, Islamic Republic of |
Responsible Party: | Leila Azadbakht, Isfahan University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01886482 History of Changes |
Other Study ID Numbers: |
high protein diet in childhood |
First Posted: | June 26, 2013 Key Record Dates |
Last Update Posted: | June 26, 2013 |
Last Verified: | June 2013 |
Additional relevant MeSH terms:
Hypoalphalipoproteinemias Tangier Disease Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Hypolipoproteinemias |
Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |