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

Brief Title

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

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 Description

      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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

the amount of weight reduction in two dietary groups

Secondary Outcome

 LDL-C (mg/dl

Condition

Body Mass Index Quantitative Trait Locus 8 Disorder

Intervention

nutrition intervention

Study Arms / Comparison Groups

 nutrition intervention
Description:  high protein diet

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

63

Start Date

January 2011

Completion Date

August 2012

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

          -  women aged between 20-65 years

          -  BMI > 25 kg/m2

          -  were no smoker

          -  no history of renal, liver, metabolic diseases or type 1 or 2 diabetes

        Exclusion Criteria:

          -  had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal
             -diseases

          -  had macroalbuminuria

          -  were pregnancy or lactating
      

Gender

Female

Ages

20 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Leila Azadbakht, PhD, , 



Administrative Informations


NCT ID

NCT01763528

Organization ID

high protein in women


Responsible Party

Principal Investigator

Study Sponsor

Isfahan University of Medical Sciences


Study Sponsor

Leila Azadbakht, PhD, Principal Investigator, Isfan University of Medical Sciences


Verification Date

January 2013