Effects of a High Protein Diet on Clinical Outcomes in Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure, Diabetes Mellitus

In brief

This research project was designed to study the role of dietary modifications in heart failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically, the purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification program of either a high protein (30 % of total calories from protein) group will have a significant improvement in weight reduction, quality of life and clinical outcomes compared to a standardized protein (15% of total calories from protein) group.

Key facts

Study ID

NCT01423266

Run by

University of California, Irvine

People needed

78

Starts

2009-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• obese (BMI > 27 kg/m2);
• history of type 2 DM or documented impaired fasting glucose (IFG) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or Metabolic Syndrome ( as defined by the International Diabetes Federation 2011
• evaluation of HF and optimization of medical therapy; and
• ischemic or idiopathic HF etiology.

You may not qualify if…

• age ≤18 years old;
• history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
• pregnancy or lactation;
• serum creatinine level > 1.5 mg/dl;*
• currently participating in a supervised weight loss program;
• physician refusal to permit patient participation in the study; and
• weight loss of >6% in the last 6 months
• gout or history of gout

Where it is running

• University of California Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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