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

This study is currently recruiting participants.
Verified February 2013 by University of California, Irvine
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01423266
First received: August 15, 2011
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Heart Failure
Diabetes Mellitus
Procedure: 12-week supervised weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Examining the Effects of a High Protein Diet on Adiposity and Cardiac Structure in Patients With Heart Failure, Obesity, and Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Change from Baseline in adiposity (and body composition; i.e., % body fat)) [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in lipid profiles (while controlling for statin drug dosage) [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]
  • Change from Baseline in glycemic control and insulin resistance [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]
  • Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement) [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]
  • Change from Baseline in levels of quality of life [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in Cardiac Structure [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]
  • Change in Cardiac Function [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Protein Group
12-week supervised weight loss program consisting of a HP diet defined as 30% of energy from protein, 40% from carbohydrates and 30% from fat
Procedure: 12-week supervised weight loss intervention
Patients in the 2 study arms will participate in an intensive 12-week supervised weight loss intervention and will be seen by the same dietician at regular intervals: baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Participants will receive personalized nutrition counseling and support during each of these visits. Participants will be randomized to either the HP or SP diet and assigned to receive one of two standard structured energy-restricted meal plans (1200, 1500 Kcal/day) based on the computed calorie deficit
Other Names:
  • weight management
  • diet
  • nutritional supervision
Active Comparator: Standard Protein Group
12-week supervised weight loss program consisting of a SP diet defined as 15% of energy from protein, 55% from carbohydrates and 30% from fat
Procedure: 12-week supervised weight loss intervention
Patients in the 2 study arms will participate in an intensive 12-week supervised weight loss intervention and will be seen by the same dietician at regular intervals: baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Participants will receive personalized nutrition counseling and support during each of these visits. Participants will be randomized to either the HP or SP diet and assigned to receive one of two standard structured energy-restricted meal plans (1200, 1500 Kcal/day) based on the computed calorie deficit
Other Names:
  • weight management
  • diet
  • nutritional supervision

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423266

Contacts
Contact: Lorraine S. Evangelista, PhD,RN,FAAN 949-824-1771 evangell@hs.uci.edu
Contact: Marjan Motie, Ph.D. 949-824-8707 mmotie@hs.uci.edu

Locations
United States, California
University of California Medical Center Recruiting
Orange, California, United States, 92868
Contact: Evangelista       evangell@hs.uci.edu   
Contact: Motie       mmotie@hs.uci.edu   
Principal Investigator: Lorraine S Evangelista, PhD,RN,FAAN         
Sponsors and Collaborators
University of California, Irvine
University of California, Los Angeles
Investigators
Principal Investigator: Lorraine S Evangelista, PhD,RN,FAAN University of California, Irvine
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT01423266     History of Changes
Other Study ID Numbers: 1 R01 HL093466-01
Study First Received: August 15, 2011
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
High Protein Diet in heart failure
obesity and heart failure
Weight management in Heart failure
heart failure, diabetes and obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014