High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women
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|ClinicalTrials.gov Identifier: NCT01763528|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : January 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Body Mass Index Quantitative Trait Locus 8 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, we aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.
Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (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, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||High Protein Diet , CRP and CVD Risk Factors|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: nutrition intervention
high protein diet
Other: nutrition intervention
high protein diet
No Intervention: control group
- the amount of weight reduction in two dietary groups [ Time Frame: 3 months ]weight reduction (kg)
- LDL-C (mg/dl [ Time Frame: 3 months ]measurement of LDL-C (mg/dl), HDL-C (mg/dl), total cholesterol (mg/dl), fasting blood glucose (mg/dl), systolic and diastolic blood pressure (mmHg), c reactive protein by the measurement of blood samples.
- HDL-C (mg/dl) [ Time Frame: 3 months ]
- total cholesterol (mg/dl) [ Time Frame: 3 months ]
- fasting blood glucose(mg/dl) [ Time Frame: 3 months ]
- blood pressure (mmHg) [ Time Frame: 3 months ]
- C-reactive protein (mc/dl) [ Time Frame: 3 months ]
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): NCT01763528
|Principal Investigator:||Leila Azadbakht, PhD||Isfan University of Medical Sciences|