High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763528
|Principal Investigator:||Leila Azadbakht, PhD||Isfan University of Medical Sciences|