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

Primary Purpose

Body Mass Index Quantitative Trait Locus 8 Disorder, Tangier Disease

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

nutrition intervention

About this trial

This is an interventional health services research trial for Body Mass Index Quantitative Trait Locus 8 Disorder focused on measuring body weight, Low-density-lipoprotein-type

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

nutrition intervention

control group

Arm Description

high protein diet

control diet

Outcomes

Primary Outcome Measures

the amount of weight reduction in two dietary groups

weight reduction (kg)

Secondary Outcome Measures

LDL-C (mg/dl

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)

total cholesterol (mg/dl)

fasting blood glucose(mg/dl)

blood pressure (mmHg)

C-reactive protein (mc/dl)

Full Information

NCT ID

NCT01763528

First Posted

December 18, 2012

Last Updated

January 8, 2013

Sponsor

Isfahan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01763528

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Mass Index Quantitative Trait Locus 8 Disorder, Tangier Disease

Keywords

body weight, Low-density-lipoprotein-type

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nutrition intervention

Arm Type

Active Comparator

Arm Description

high protein diet

Arm Title

control group

Arm Type

No Intervention

Arm Description

control diet

Intervention Type

Other

Intervention Name(s)

nutrition intervention

Intervention Description

high protein diet

Primary Outcome Measure Information:

Title

the amount of weight reduction in two dietary groups

Description

weight reduction (kg)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

LDL-C (mg/dl

Description

Time Frame

3 months

Title

HDL-C (mg/dl)

Time Frame

3 months

Title

total cholesterol (mg/dl)

Time Frame

3 months

Title

fasting blood glucose(mg/dl)

Time Frame

3 months

Title

blood pressure (mmHg)

Time Frame

3 months

Title

C-reactive protein (mc/dl)

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leila Azadbakht, PhD

Organizational Affiliation

Isfan University of Medical Sciences

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

23986778

Citation

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.

Results Reference

derived

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

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