Increasing Enrollment for the Nutrition for Precision Health Study at the University of North Carolina Chapel Hill Clinical Center

About This Grant

The NIH-funded Nutrition for Precision Health Study (NPH) is a discovery science project established in January 2022 for the purpose of elucidating variability in individual response to dietary exposures. The study is the first ancillary study of the All of Us Research Program (AoURP). The University of North Carolina at Chapel Hill is home to one of the six clinical centers in the NPH consortium (UNC-CC, NIH-UG1HD107692, MPIs Mayer-Davis and Tate). NPH participants, all of whom are participants in AoURP, begin with NPH Module 1 which is a cross-sectional study designed to carefully characterize dietary intake, a wide array of behavioral and social factors, as well as physiological measures including assessments during a liquid mixed meal tolerance test. Module 1 assessments occur over an 8-10 day period. A subset of participants who have completed Module 1 then go on to participate in either Module 2 or Module 3, both of which involve a controlled feeding study to assess response to each of three different test diets, using a cross-over design. Each diet is consumed for a period of two weeks, with a minimum of a two week washout period. At the UNC-CC, we offer only Modules 1 and 2 (free-living); not Module 3 (domiciled). Our clinical center is co-located in Chapel Hill and in Kannapolis, NC, approximately two hours apart by car. We are unique in that we established an AoURP recruitment center for the purpose of conducting the NPH study. As we have been successful both in enrolling participants into AoURP and then recruiting participants into Modules 1 and 2, the UNC-CC proposes to build upon our primary infrastructure to increase our sample size and thereby contribute to the national consortium as we seek to ensure the overall success of the study. Specifically, we request additional funds to increase enrollment as follows: • Module 1: 1145 participants (increase of 145 participants from our initial enrollment target) • Module 2: 430 participants (increase of 20 participants from our most recent enrollment target) We propose an enrollment split with approximately 50% of participants seen in Chapel Hill and 50% of participants seen at the Nutrition Research Institute (NRI) in Kannapolis with most of the increased enrollment target for M2 to be enrolled at NRI. The NRI is well suited for this expansion given the capacity of the metabolic kitchen at NRI to accommodate the majority of these additional M2 participants.