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

High Protein Diet , CRP and CVD Risk Factors

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01763528
Enrollment
63
Registered
2013-01-09
Start date
2011-01-31
Completion date
2012-08-31
Last updated
2013-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Mass Index Quantitative Trait Locus 8 Disorder, Tangier Disease

Keywords

body weight, Low-density-lipoprotein-type

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.

Interventions

OTHERnutrition intervention

high protein diet

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
the amount of weight reduction in two dietary groups3 monthsweight reduction (kg)

Secondary

MeasureTime frameDescription
HDL-C (mg/dl)3 months
total cholesterol (mg/dl)3 months
LDL-C (mg/dl3 monthsmeasurement 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.
blood pressure (mmHg)3 months
C-reactive protein (mc/dl)3 months
fasting blood glucose(mg/dl)3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026