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Completed

NCT Number: NCT01763528

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

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

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Key information

Conditions

Body Mass Index Quantitative Trait Locus 8 Disorder Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypoalphalipoproteinemias Hypolipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms Tangier Disease

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Intervention

Other

high protein diet

Primary outcomes

  1. the amount of weight reduction in two dietary groups

    Time frame: 3 months

    weight reduction (kg)

Secondary outcomes

  1. LDL-C (mg/dl

    Time frame: 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.

  2. HDL-C (mg/dl)

    Time frame: 3 months

  3. total cholesterol (mg/dl)

    Time frame: 3 months

  4. fasting blood glucose(mg/dl)

    Time frame: 3 months

  5. blood pressure (mmHg)

    Time frame: 3 months

  6. C-reactive protein (mc/dl)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

High Protein Diet , CRP and CVD Risk Factors

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2013
Registry last updated
Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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