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

Tangier Disease Clinical Trial

Official title:

High Protein Diet , CRP and CVD Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763528
• Other study ID #: high protein in women
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2012
• Last updated: January 8, 2013
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Mass Index Quantitative Trait Locus 8 Disorder
• Tangier Disease

Intervention

Other:
• nutrition intervention
high protein diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of weight reduction in two dietary groups	weight reduction (kg)	3 months	Yes
Secondary	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	Yes
Secondary	HDL-C (mg/dl)		3 months	Yes
Secondary	total cholesterol (mg/dl)		3 months	Yes
Secondary	fasting blood glucose(mg/dl)		3 months	Yes
Secondary	blood pressure (mmHg)		3 months	Yes
Secondary	C-reactive protein (mc/dl)		3 months	Yes