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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Mood Supplementation | Experimental | The New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root. |
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| Placebo Supplementation | Placebo Comparator | The placebo includes rice bran and maltodextrin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Ingredient Herbal Supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cortisol awakening response (mg/dL) over 8 weeks | Three salivary cortisol measurements to determine cortisol awakening response (mg/dL) from baseline to 8 weeks | Change from baseline cortisol awakening response (mg/dL) at 8 weeks |
| Change in resting heart rate (beats per minute) over 8 weeks | Manual radial pulse measurement of resting heart rate (beats per minute) at baseline and 8 weeks | Change from baseline resting heart rate (beats per minute) response at 8 weeks |
| Change in resting systolic and diastolic blood pressure (mm Hg) over 8 weeks | Digital sphygmomanometer measurement of resting systolic and diastolic blood pressure (mm Hg) at baseline and 8 weeks | Change from baseline resting systolic and diastolic blood pressure (mm Hg) at 8 weeks |
| Change in depression, anxiety and stress scores (0-34) over 8 weeks | Depression, Anxiety and Stress Scale Questionnaire (DASS-21, 0-34) to assess depression, anxiety and stress scores from baseline to 8 weeks | Change from baseline DASS-21 score at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Idaho | Moscow | Idaho | 83844 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35635482 | Derived | Brown AF, Richardson CME, Newby N, Pulsipher S, Hoene T. Effect of a Multi-Ingredient Supplement Designed to Regulate Mood on Physiological and Psychological Outcomes: A Randomized, Double-Blind, Placebo-Controlled Trial. J Diet Suppl. 2023;20(4):631-642. doi: 10.1080/19390211.2022.2077880. Epub 2022 May 30. |
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| Placebo Supplement | Dietary 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. |
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