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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01763528
First received: December 18, 2012
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Body Mass Index Quantitative Trait Locus 8 Disorder
Tangier Disease
 Other: nutrition intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: High Protein Diet , CRP and CVD Risk Factors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • the amount of weight reduction in two dietary groups [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    weight reduction (kg)


Secondary Outcome Measures:
  • LDL-C (mg/dl [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • total cholesterol (mg/dl) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • fasting blood glucose(mg/dl) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • blood pressure (mmHg) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • C-reactive protein (mc/dl) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nutrition intervention
high protein diet
 Other: nutrition intervention
high protein diet
No Intervention: control group
control diet

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763528

Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Leila Azadbakht, PhD Isfan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Leila Azadbakht, Isfahan University of Medical Sciences,, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01763528     History of Changes
Other Study ID Numbers: high protein in women
Study First Received: December 18, 2012
Last Updated: January 8, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Isfahan University of Medical Sciences:
body weight
Low-density-lipoprotein-type

Additional relevant MeSH terms:
Tangier Disease
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hypoalphalipoproteinemias
Hypolipoproteinemias
 Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013