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

January 8, 2013 updated by: Leila Azadbakht, Isfahan University of Medical Sciences

High Protein Diet , CRP and CVD Risk Factors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: nutrition intervention
high protein diet
Other: nutrition intervention
high protein diet
NO_INTERVENTION: control group
control diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the amount of weight reduction in two dietary groups
Time Frame: 3 months
weight reduction (kg)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
HDL-C (mg/dl)
Time Frame: 3 months
3 months
total cholesterol (mg/dl)
Time Frame: 3 months
3 months
fasting blood glucose(mg/dl)
Time Frame: 3 months
3 months
blood pressure (mmHg)
Time Frame: 3 months
3 months
C-reactive protein (mc/dl)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • high protein in women

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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