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

NCT01423266 | Completed DMC

• 1 other identifier: 1R01HL093466-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in adiposity (and body composition; i.e., % body fat))

  3 months and 15 months

Secondary Outcomes (4)

• 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 Outcomes (2)

• Change in Cardiac Structure

  3 months and 15 months

• Change in Cardiac Function

  3 months and 15 months

Study Arms (2)

High Protein Group

EXPERIMENTAL

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

Standard Protein Group

ACTIVE COMPARATOR

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

Interventions

12-week supervised weight loss intervention PROCEDURE

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

Also known as: weight management, diet, nutritional supervision

High Protein Group; Standard Protein Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

University of California Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lorraine S Evangelista, PhD,RN,FAAN

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 25, 2011
• Study Start: December 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 23, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)