Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Nov;36(2):371-81.
doi: 10.1016/j.cct.2013.08.004. Epub 2013 Aug 17.

Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics

Marjan Motie  1 , Lorraine S Evangelista, Tamara Horwich, Michele Hamilton, Dawn Lombardo, Dan M Cooper, Pietro R Galassetti, Gregg C Fonarow
Affiliations
Randomized Controlled Trial

Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics

Marjan Motie et al. Contemp Clin Trials. 2013 Nov.

Abstract

There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS.

Keywords: Clinical trial; Heart failure; Nutrition; Obesity.

PubMed Disclaimer

Figures

Figure 1
Figure 1. Study Conceptual Model: Illustrating the Hypothesized Effects of a HP Diet*
* The figure depicts the hypothesized effects of a HP diet on selected variables as reflected in the study aims. It does not necessarily portray the complete pathophysiologic changes that occur with HF, obesity, and DM.
Figure 2
Figure 2. Study Flow Chart
See this image and copyright information in PMC

References

    1. Klein S, Burke LE, Bray GA, Blair S, Allison DB, Pi-Sunyer X, Hong Y, Eckel RH. Clinical Implications of Obesity With Specific Focus on Cardiovascular Disease: A Statement for Professionals From the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: Endorsed by the American College of Cardiology Foundation. Circulation. 2004;110:2952–2967. - PubMed
    1. Horwich TB, Fonarow G, Hamilton MA, MacLellan WR, Woo MA, Tillisch JH. The relationship between obesity and mortality in patients with heart failure. J Am Coll Cardiol. 2001;38:789–795. - PubMed
    1. Davos CH, Doehner W, Rauchhaus M, Cicoira M, Francis D, Coats AJ, Clark AL, Anker SD. Body mass and survival in patients with chronic heart failure without cachexia: the importance of obesity. J Card Fail. 2003;9:29–35. - PubMed
    1. Lissin LW, Gauri AJ, Froelicher VF, Ghayoumi A, Myers J, Giacommini J. The prognostic value of body mass index and standard exercise testing in male veterans with congestive heart failure. J Card Fail. 2002;8:206–215. - PubMed
    1. Mosterd A, Cost B, Hoes A. The prognosis of heart failure in the general population: the Rotterdam Study. Eur Heart J. 2001;22:1318–1327. - PubMed

Publication types

Substances