Author Contributions: Dr Appel had full access to all study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Appel, Sacks, Carey, Obarzanek, Swain, Miller, Conlin, Erlinger, Charleston.
Acquisition of data: Appel, Sacks, Carey, Swain, Miller, Conlin, Charleston, McCarron, Bishop.
Analysis and interpretation of data: Appel, Sacks, Carey, Obarzanek, Swain, Miller, Erlinger, Rosner, Laranjo.
Drafting of the manuscript: Appel, Carey, Charleston.
Critical revision of the manuscript for important intellectual content: Appel, Sacks, Carey, Obarzanek, Swain, Miller, Conlin, Erlinger, Rosner, Laranjo, McCarron, Bishop.
Statistical analysis: Sacks, Carey, Rosner, Laranjo.
Obtained funding: Appel, Sacks, Carey.
Administrative, technical, or material support: Appel, Sacks, Carey, Obarzanek, Conlin, Erlinger, Laranjo.
Study supervision: Appel, Sacks, Carey, Swain, Miller, Conlin, Bishop.
Financial Disclosures: None reported.
Funding/Support: Funding for this study was provided through grants HL67098, DK63214, HL68712, and RR02635 from the National Institutes of Health. The following companies donated food: The Almond Board, International Tree Nut Council, Olivio Premium Products Inc, and The Peanut Institute.
Role of the Sponsor: The sponsor contributed to the design of the study, interpretation of data, and review of the manuscript. The sponsor also provided administrative support.
Data and Safety Monitoring Board: Barry Davis, PhD, Richard Grimm, MD (chair), Alice Lichtenstein, PhD, Jeremiah Stamler, MD, and Jackson Wright, MD.
OmniHeart Research Team: Brigham and Women’s Hospital Clinical Center: Natalie Alexander, Cassandra Carrington, BS, Kimberly Jenson, BS, Eileen Hamilton, DTR, Christian Heath, Scott McCarthy, RD, Rachel Rodek, MS, Janice Sales, David Stebbins, BS, Kristen Widican, BA, Karen Yee, MS; Brigham and Women’s Hospital Coordinating Center: Benjamin Harshfield, Melissa McEnery-Stonelake, BS; Johns Hopkins Clinical Center staff: Brett Ange, MHS, Cassie Brode, BA, Kimberly Bryant, Giti Dillon, Toya George, Mildred Green, Ella Greene, Ronea Griffin, Tara Harrison, Brittany Jiggets, Theresa Lally, RD, Gloria Lawrence, Karen McCully, MSc, Denise Monnett, Mary Myer, Dana Owens, BS, Rosetta Pearson, Joy Peterson, Charles Powell, Jennifer Smith, RD, Amber Summers, MHS, Lindsay Tankard, Letitia Thomas, Karen White, MS, Essie Wilkie; Virginia Polytechnic Institute: Katherine Phillips, PhD: Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute; Jennifer Bittner and Michael Proschan, PhD.
Presentation: Presented as a Late Breaking Clinical Trial at the American Heart Assocation, Scientific Sessions, November 2005
Acknowledgment: We are indebted to our participants for their sustained commitment to the trial.