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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423266
• Other study ID #: 1R01HL093466-01
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: May 19, 2016
• Start date: December 2009
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	University of California Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Cardiac Structure		3 months and 15 months	No
Other	Change in Cardiac Function		3 months and 15 months	No
Primary	Change from Baseline in adiposity (and body composition; i.e., % body fat))		3 months and 15 months	No
Secondary	Change from Baseline in lipid profiles (while controlling for statin drug dosage)		3 months and 15 months	No
Secondary	Change from Baseline in glycemic control and insulin resistance		3 months and 15 months	No
Secondary	Change from Baseline in peripheral blood circulation (as measured using peripheral arterial tonometry and plasma nitroxide measurement)		3 months and 15 months	No
Secondary	Change from Baseline in levels of quality of life		3 months and 15 months	No