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

NCT ID: NCT01763528

Last Updated: 2013-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Body Mass Index Quantitative Trait Locus 8 Disorder Tangier Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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nutrition intervention

high protein diet

Group Type ACTIVE_COMPARATOR

nutrition intervention

Intervention Type OTHER

high protein diet

control group

control diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nutrition intervention

high protein diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Azadbakht

Isfahan University of Medical Sciences,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leila Azadbakht, PhD

Role: PRINCIPAL_INVESTIGATOR

Isfan University of Medical Sciences

References

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Azadbakht L, Izadi V, Surkan PJ, Esmaillzadeh A. Effect of a High Protein Weight Loss Diet on Weight, High-Sensitivity C-Reactive Protein, and Cardiovascular Risk among Overweight and Obese Women: A Parallel Clinical Trial. Int J Endocrinol. 2013;2013:971724. doi: 10.1155/2013/971724. Epub 2013 Aug 6.

Reference Type DERIVED
PMID: 23986778 (View on PubMed)

Other Identifiers

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high protein in women

Identifier Type: -

Identifier Source: org_study_id

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