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

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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… Click to show full abstract

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: randomized double; double blind; car; placebo controlled; blind placebo; controlled trial

Journal Title: Journal of dietary supplements
Year Published: 2022

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