title: 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.
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.
authors: University of California Irvine, Irvine, CA, United States. Electronic address: mmotie@uci.edu.
authors: Marjan
authors: M
authors: Motie
authors: Lorraine S
authors: LS
authors: Evangelista
authors: Tamara
authors: T
authors: Horwich
authors: Michele
authors: M
authors: Hamilton
authors: Dawn
authors: D
authors: Lombardo
authors: Dan M
authors: DM
authors: Cooper
authors: Pietro R
authors: PR
authors: Galassetti
authors: Gregg C
authors: GC
authors: Fonarow
mesh_terms: D000273:Adipose Tissue / Q000378:metabolism; D001835:Body Weight; D002985:Clinical Protocols; D004032:Diet / Q000379:methods; D004044:Dietary Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000178:diet therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications* / Q000178:diet therapy; D010349:Patient Compliance; D016896:Treatment Outcome
chemical_list: D004044:Dietary Proteins
keywords: Clinical trial; Heart failure; Nutrition; Obesity
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