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

Study Overview
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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.

Official Title
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High Protein Diet , CRP and CVD Risk Factors

Conditions
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Body Mass Index Quantitative Trait Locus 8 Disorder, Tangier Disease

Intervention / Treatment
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* Other: nutrition intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nutrition intervention<br>high protein diet | Other: nutrition intervention<br>* high protein diet<br>|
| No Intervention: control group<br>control diet | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body weight, Low-density-lipoprotein-type