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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Tangier Disease; Body Mass Index Quantitative Trait Locus 8 Disorder

Treatments: Other: nutrition intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01763528

high protein in women

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

63 participants in 2 patient groups

nutrition intervention

Active Comparator group

Description:

high protein diet

Treatment:

Other: nutrition intervention

control group

No Intervention group

Description:

control diet