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

Examining the Effects of a High Protein Diet on Adiposity and Cardiac Structure in Patients With Heart Failure, Obesity, and Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes Mellitus
• Intervention / Treatment: Procedure: 12-week supervised weight loss intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: diet; weight management; 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: diet; weight management; nutritional supervision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in adiposity (and body composition; i.e., % body fat))	3 months and 15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in lipid profiles (while controlling for statin drug dosage)	3 months and 15 months
Change from Baseline in glycemic control and insulin resistance	3 months and 15 months
Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement)	3 months and 15 months
Change from Baseline in levels of quality of life	3 months and 15 months

Other Outcome Measures

Outcome Measure	Time Frame
Change in Cardiac Structure	3 months and 15 months
Change in Cardiac Function	3 months and 15 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Lorraine S Evangelista, PhD,RN,FAAN, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (ESTIMATE): August 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: High Protein Diet in heart failure; obesity and heart failure; Weight management in Heart failure; heart failure, diabetes and obesity
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Failure; Diabetes Mellitus
• Other Study ID Numbers: 1R01HL093466-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data management and analysis is in progress.