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.

Keywords:

• Collegiate
• cortisol
• mood
• multi-ingredient supplement
• RCT

Disclosure statement

The authors have no conflicts of interest to disclose.

Data availability statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy of human subjects.

Additional information

Funding

This work was supported by ONNIT Labs under Grant 18743 (DM2517).

Notes on contributors

Ann F. Brown

Ann Brown is an assistant professor and director of the Human Performance Laboratory at the University of Idaho. Her research focuses on interactions between metabolism, body composition and performance including the impacts of supplementation on overall health. Much of her research focuses on a collegiate population and more specifically collegiate dancers’ optimal nutrition and training.

Clarissa M. E. Richardson

Clarissa Richardson is an assistant professor of psychology at Illinois College. Her research investigates of perfectionism impacts coping with stress, particularly daily stress. She uses the cortisol stress response to physiologically assess stress. She has performed intervention research to investigate the impacts of mindfulness and emotion regulation.

Nathan Newby

Nathan Newby is a second year medical student at the University of Washington School of Medicine WWAMI. He was engaged in undergraduate research at the University of Idaho as a research assistant and laboratory manager in multiple laboratories including the Comparative Neuromuscular Biomechanics Laboratory and the Human Performance Laboratory.

Sydney Pulsipher

Sydney Pulsipher was engaged in research during undergraduate work at the University of Idaho where she was a research assistant and laboratory coordinator in the Human Performance Laboratory. She later went on to continue her education at Boise State University to earn her Master’s in Public Health.

Talje Hoene is a mental health program coordinator for the University of Idaho College of Agriculture and Life Sciences Extension program. She engaged in research as an undergraduate in psychology at the University of Idaho and assisted in coordinating numerous studies.