Clinical Trial: High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: High Protein Diet , CRP and CVD Risk Factors

Brief Summary: The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Detailed Summary:

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.


Sponsor: Isfahan University of Medical Sciences

Current Primary Outcome: the amount of weight reduction in two dietary groups [ Time Frame: 3 months ]

weight reduction (kg)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Isfahan University of Medical Sciences

Dates:
Date Received: December 18, 2012
Date Started: January 2011
Date Completion:
Last Updated: January 8, 2013
Last Verified: January 2013