Mental Health Wellness 1
Conditions
Keywords
cortisol, mood
Brief summary
The primary purpose of this study is to assess the effectiveness of ONNIT Lab's New Mood™ dietary supplement in supporting optimal mood balance and reducing daily stress among collegiate-aged men and women. To be considered for this study, the participant must meet the following criteria: (1) current undergraduate student at the University of Idaho between 18-24 years of age, (2) have no known allergies to the ingredients of New Mood™ (Niacin, Vitamin B6, Magnesium, Valerian Extract, Lemon Balm Extract, L-Tryptophan. 5-Hydroxytryptophan, and Inositol) or the placebo (rice bran and maltodextrin), (3) not currently taking any mood/sleep supplementation or medications, (4) not currently seeking therapy or diagnosed with a psychological disorder, (5) not regularly using cigarettes, marijuana, or other illicit drugs, and (6) not pregnant or breastfeeding.
Interventions
DIETARY_SUPPLEMENTMulti-Ingredient Herbal Supplement
Weeks 0-2 all participants consumed a placebo lead-in period and weeks 2-6 were intervention weeks. Throughout the 8 weeks (2 weeks placebo lead-in and 6 weeks intervention) participants were asked to consume 2 capsules (multi-ingredient supplement) upon waking in the morning and 2 capsules (multi-ingredient supplement) before bed.
DIETARY_SUPPLEMENTPlacebo Supplement
Weeks 0-8 all participants consumed a placebo. Throughout the 8 weeks participants were asked to consume 2 capsules (placebo) upon waking in the morning and 2 capsules (placebo) before bed.
Sponsors
University of Idaho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Currently enrolled collegiate men and women at the University of Idaho
Exclusion criteria
* Currently taking mood or sleep enhancing supplementation/medication * Currently participating in counseling and/or therapy sessions * Previously diagnosed with a psychological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cortisol awakening response (mg/dL) over 8 weeks | Change from baseline cortisol awakening response (mg/dL) at 8 weeks | Three salivary cortisol measurements to determine cortisol awakening response (mg/dL) from baseline to 8 weeks |
| Change in resting heart rate (beats per minute) over 8 weeks | Change from baseline resting heart rate (beats per minute) response at 8 weeks | Manual radial pulse measurement of resting heart rate (beats per minute) at baseline and 8 weeks |
| Change in resting systolic and diastolic blood pressure (mm Hg) over 8 weeks | Change from baseline resting systolic and diastolic blood pressure (mm Hg) at 8 weeks | Digital sphygmomanometer measurement of resting systolic and diastolic blood pressure (mm Hg) at baseline and 8 weeks |
| Change in depression, anxiety and stress scores (0-34) over 8 weeks | Change from baseline DASS-21 score at 8 weeks | Depression, Anxiety and Stress Scale Questionnaire (DASS-21, 0-34) to assess depression, anxiety and stress scores from baseline to 8 weeks |
Countries
United States
Outcome results
None listed