Clinical trial NCT01423266: Effects of a High Protein Diet on Clinical Outcomes in Heart Failure
Official title: Examining the Effects of a High Protein Diet on Adiposity and Cardiac Structure in Patients With Heart Failure, Obesity, and Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Diabetes Mellitus
Keywords: High Protein Diet in heart failure
obesity and heart failure
Weight management in Heart failure
heart failure, diabetes and obesity
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2011-08-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Clinical management of heart failure (HF) related to obesity and diet recommendations currently lacks a strong scientific basis, and clinicians are divided in their approach to diet recommendations for this patient population. It has been shown that in extremely obese HF patients, weight reduction improves cardiac structure and function as well as functional status and symptomatology. Evidence on the impact of voluntary weight loss on improvement in survival in obese HF patients, however, is limited.

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.

In addition to dietary interventions, participants in both groups with be given an exercise prescription and encouraged to exercise for 20-30 minutes at least 3-5 times each week as tolerated. They will also continue to receive usual medical care, advice and other support for their condition from their cardiologist or medical physician. Both sets of participants will utilize self-monitoring tools to assist with diet compliance and behavior change. These self-monitoring tools are mandatory and will be collected and analyzed. At each visit, subjects will also be asked to will also be asked to have their weight and waist circumference measured and, at select visits, they will provide a 24 hour recall to assess fullness with the overall diet. Subjects will be given a 3-day food (3DFR) record at baseline, which will be returned at the the 2-week, 4- week and 8-week visits, and will also complete the 3DFR at three months.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in adiposity (and body composition; i.e., % body fat))
timeFrame: 3 months and 15 months
Secondary outcomes:
measure: Change from Baseline in lipid profiles (while controlling for statin drug dosage)
timeFrame: 3 months and 15 months
measure: Change from Baseline in glycemic control and insulin resistance
timeFrame: 3 months and 15 months
measure: Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement)
timeFrame: 3 months and 15 months
measure: Change from Baseline in levels of quality of life
timeFrame: 3 months and 15 months
Other outcomes:
measure: Change in Cardiac Structure
timeFrame: 3 months and 15 months
measure: Change in Cardiac Function
timeFrame: 3 months and 15 months
Locations:
city: Orange
country: United States
facility: University of California Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Lorraine S Evangelista, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References: