Comparing the Study Populations in Dietary Supplement and Drug Clinical Trials for Metabolic Syndrome and Related Disorders

Clinical trials are essential in exploring the safety and efficacy of a new intervention. However, restrictive eligibility criteria pose recruitment challenges that could prolong study durations and reduce study generalizability to the real-world population. The objective of this study is to compare the study populations of dietary supplement (DS) and drug trials on metabolic syndrome related conditions. Using the COMPACT database, we retrieved the DS and drug trials related to metabolic syndrome and performed aggregate analyses on the study populations with respect to various quantitative eligibility criteria. We also extracted and compared baseline characteristics, both quantitative and qualitative, of recruited patients in completed trials. We found similarities and differences in baseline characteristics of enrolled patients between drug and DS clinical trials on metabolic syndrome-related conditions. This comparative aggregate analysis is an initial step towards improving patient recruitment efficacy and population representativeness for clinical trials across conditions and intervention types