Menu design and selection for multicenter controlled feeding studies: process used in the Dietary Approaches to Stop...

Outpatient feeding studies are being used increasingly more often than inpatient studies because they are less expensive to conduct and less disruptive to participants' daily lives. Frequently, however, they are more difficult to implement. Studies involving multiple feeding centers add an additional layer of cooperation, coordination, and standardization to the already complex task of developing and delivering research diets. This was true for the 4-year Dietary Approaches to Stop Hypertension (DASH) trial, one of the first multicenter outpatient controlled feeding studies. This 4-center, randomized clinical trial was designed to compare the effects of 3 dietary patterns on blood pressure. After a year of development, 3 sets of 7-day cycle menus that met the study nutrient criteria and that were appropriate for varying food production routines and staffing patterns at the 4 clinical centers were adopted. The major development tasks were: defining methodologies to guide menu design and food production; selecting a nutrient database and calculating nutrient content of menus; evaluating and selecting the menus; and adjusting the menus for final use. The purpose of this article is to describe the steps and considerations in the design and selection of menus for the DASH trial, a process applicable to all well-controlled feeding studies.