A Phase 3 interventional study of nutrition intervention in Body Mass Index Quantitative Trait Locus 8 Disorder and Tangier Disease, sponsored by Isfahan University of Medical Sciences. Completed. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-09.
Sponsored by Isfahan University of Medical Sciences · Phase 3, Interventional, and Health services research
The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.
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.
1,239 studies on the registry are indexed under Body Weight; 137 are open to participants now.
This study's enrollment of 63 is close to the median of 66 across 960 interventional studies indexed under Body Weight.
Browse Body Weight studies →Isfahan University of Medical Sciences is the lead sponsor of 149 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
high protein diet
Other: nutrition intervention
control diet
high protein diet
the amount of weight reduction in two dietary groups
weight reduction (kg)
Time frame: 3 months
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.
Time frame: 3 months
HDL-C (mg/dl)
Time frame: 3 months
total cholesterol (mg/dl)
Time frame: 3 months
fasting blood glucose(mg/dl)
Time frame: 3 months
blood pressure (mmHg)
Time frame: 3 months
C-reactive protein (mc/dl)
Time frame: 3 months
No study locations are listed for this record.
The record gives a start of Jan 2011, a primary completion of Jul 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Isfahan University of Medical Sciences →