Study concept and design: Sacks, Carey, Miller, Swain, White, Yee, Appel.
Acquisition, analysis, or interpretation of data: Sacks, Carey, Anderson, Miller, Copeland, Charleston, Harshfield, Laranjo, McCarron, Yee, Appel.
Drafting of the manuscript: Sacks, Carey, Anderson, Copeland, Laranjo, Swain.
Critical revision of the manuscript for important intellectual content: Sacks, Carey, Anderson, Miller, Charleston, Harshfield, McCarron, White, Yee, Appel.
Statistical analysis: Carey, Harshfield, Laranjo.
Obtained funding: Sacks, Carey, Appel.
Administrative, technical, or material support: Carey, Miller, Copeland, Harshfield, Laranjo, Swain, Appel.
Study supervision: Sacks, Carey, Anderson, Miller, McCarron, Appel.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sacks was an expert witness in litigation involving POM Wonderful, Hershey, Unilever, and Keebler. No other disclosures were reported.
Funding/Support: The study was supported by an investigator-initiated grant from the National Heart, Lung, and Blood Institute (R01HL084568) and received additional support from National Institute of Diabetes and Digestive and Kidney Diseases (R21 DK098720-02); the Harvard Clinical and Translational Science Center (8UL1TR0001750-05) from the National Center for Advancing Translational Science; and the general clinical research center at Brigham and Women’s Hospital (M01-02635).
Role of the Funders/Sponsors: The investigators were responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. The funding agency provided critical review of the research grant application and the protocol and monitored the progress of the study. The study received donations of some foods that were used in the study diets from Almond Board of California, Kraft Foods, Cabot Cheese, Rudolph’s Bakery of Toronto Canada, and McCormick Seasonings. These companies were not involved in the design, execution, analysis, interpretation, or manuscript writing or critique.
Additional Contributions: We thank David S. Ludwig, MD, PhD, Children’s Hospital, Boston, for consultation on the design and execution of this study and for critical reading and comments on the manuscript for which he received compensation. We thank Catherine Loria, PhD, the program officer at the National Heart, Lung, and Blood Institute, who monitored the progress of the study; and the data and safety monitoring committee (Janet King, PhD, Chair, Children’s Hospital of Oakland Research Institute; Barry Davis, MD, University of Texas School of Public Health, Houston; Henry Ginsberg, MD, Columbia University College of Physicians and Surgeons, New York; Alice Lichtenstein, DSc, Tufts University, Boston; and Edward Horton, MD, Joslin Diabetes Center, Boston); these colleagues did not receive compensation. We also thank the Frederick Church of the Brethren, Frederick, Maryland, which provided space for distribution of food to study participants.