A yeast-based product (EpiCor ® , a dried Saccharomyces cerevisiae fermentate) was compared to placebo to determine effects on the incidence and duration of cold and flu-like symptoms in healthy sub- jects recently vaccinated for seasonal influenza. In a 12-week, ran- domized, double-blind, placebo-controlled clinical trial, 116 partici- pants received daily supplementation with 500 mg of EpiCor or place- bo for 12 weeks. Data collected included periodic in-clinic examina- tions and serologic evaluations at baseline, 6- and 12-weeks. Subjects also utilized a standardized self-report symptom diary dur- ing the study. Participants receiving the yeast-based product had sig- nificantly fewer symptoms and significantly shorter duration of symptoms when compared with subjects taking a placebo. Key Words: Influenza, Saccharomyces cerevisiae, yeast, EpiCor, common cold, flu, dietary supplement. 50 UROLOGIC NURSING / February 2008 / Volume 28 Number 1 I mmune modulation that includes suppression or enhancement of immune function has become either a primary or potential form of adjuvant preventive medical treatment, and is an ongoing focus of research (Ault, 2007; Chiarella, Massi, DeRobertis, Signon, & Fazio, 2007). For example, immune suppression is utilized for more complex dis- eases, such as rheumatic arthri- tis, asthma, and inflammatory bowel disease (Leath, Singla, & Peters, 2005; Williams, Paleolog, & Feldmann, 2007). Other condi- tions, such as allergic reactions, also require down-regulation of immune function, usually with less intensity, and numerous over-the-counter treatments are Effects of a Modified Yeast Supplement on Cold/Flu Symptoms Mark A. Moyad Larry E. Robinson Edward T. Zawada, Jr. Julie M. Kittelsrud Ding-Geng Chen Stuart G. Reeves Susan E. Weaver Mark A. Moyad, MD, MPH, is the Jenkins/Pokempner Director, Preventive and Alternative Medicine, University of Michigan Medical Center, Department of Urology, Ann Arbor, MI. Larry E. Robinson, PhD, is Vice President, Scientific Affairs, Embria Health Sciences Ankeny, IA. Edward T. Zawada, Jr., MD, is Medical Director, Avera North Central Kidney Institute, Sioux Falls, SD. Julie M. Kittelsrud, MSN, RN, CNP, is a Nurse Practitioner, Avera Research Institute, Sioux Falls, SD. Ding-Geng Chen, PhD, is a Professor, Department of Mathematics and Statistics, South Dakota State University, Brookings, SD. Stuart G. Reeves, PhD, is Director of Research and Development, Embria Health Sciences, Ankeny, IA. Susan E.Weaver, MSN, RN, CNP, is a Nurse Practitioner, Avera Research Institute, Sioux Falls, SD. Introduction Many over-the-counter products claim to reduce symptoms associated with cold and flu. This is the largest randomized trial to date to examine the impact of a daily modified yeast- based product (EpiCor ® , a dried Saccharomyces cerevisiae fermen- tate) compared to placebo on the inci- dence and duration of cold and flu-like symptoms in healthy subjects recently vaccinated for seasonal influenza. Objective To determine if a modified yeast- based dietary supplement (EpiCor) taken daily reduces the incidence and duration of colds or flu-like sympto- matic features in a group of healthy individuals recently vaccinated against seasonal flu (influenza). Design and Method A 12-week experimental, double- blind, placebo-controlled study of 116 randomized, healthy participants with up-to-date vaccination histories received daily supplementation with 500 mg of EpiCor or placebo for 12 weeks. Clinical outcome measure- ments included periodic in-clinic examinations at baseline, 6- and 12- weeks; participants also utilized a standardized self-report symptom diary during the entire study. Com- prehensive laboratory serologic analy- sis was performed during each clinic visit. Results Subjects receiving EpiCor experi- enced a statistically significant reduc- tion in the incidence (p = 0.01) and duration (p = 0.03) of colds or flu com- pared with participants receiving placebo. Additionally, subjects in the EpiCor group experienced a non-sig- nificant (p = 0.23) reduction in adverse events compared to placebo. Conclusions Daily nutritional supplementation with 500 mg of EpiCor may be an effective adjuvant preventive treatment in patients recently vaccinated for sea- sonal influenza. This yeast-based intervention also demonstrated a safe- ty profile similar to a placebo. Future studies should focus on the use of this product as a potential single agent to reduce cold and flu-like symptoms in healthy individuals. Level of Evidence – Level II Do Not Reprint For Personal Use Only