Effect of a Multi-Ingredient Supplement Designed to Regulate Mood on Physiological and Psychological Outcomes: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Stress is inevitable in college, and many students utilize alternatives to professional help such as supplements to manage stress, anxiety, or depression. A randomized, double-blind, placebo-controlled trial was conducted to assess the effectiveness of a multi-ingredient supplement (MIS) in supporting optimal mood balance and reducing daily stress among healthy collegiate-aged students (clinicaltrials.gov, NCT05109923). Participants (age 18-22) were randomly assigned to a placebo (PLA; n = 29) or MIS (n = 27) group and were asked to consume 2 capsules upon waking and before bed. Resting heart rate, blood pressure and salivary cortisol awakening response (CAR) were measured at weeks 2, 5 and 8. Depression, anxiety, stress, and affect were assessed weekly. There was a significant negative linear change in CAR, depression, stress, positive and negative affect throughout the study although only CAR differed by group. From week 2 to 5, MIS decreased, on average, from 0.22 μg/dL to 0.14 μg/dL (-0.8 μg/dL), whereas PLA, on average, increased from 0.11 μg/dL to 0.17 μg/dL. MIS continued to experience a decline in CAR, ending the study with an average CAR of 0.08 μg/dL. These results suggest that MIS may help maintain a healthy physiological response during stressful life events.