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

Phase 3

Completed

• Conditions: Body Mass Index Quantitative Trait Locus 8 Disorder; Tangier Disease
• Interventions: Other: nutrition intervention

• Registration Number: NCT01763528
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Study First Submitted: 2012-12-18
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Study First Posted: 2013-01-09
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutrition intervention	nutrition intervention	high protein diet

Primary Outcome Measures

Name	Time	Method
the amount of weight reduction in two dietary groups	3 months	weight reduction (kg)

Secondary Outcome Measures

Name	Time	Method
LDL-C (mg/dl	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.
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