Onnit Labs New Mood Supplementation in Healthy College Students

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Onnit New Mood Supplementation in Healthy Collegiate Men and Women

Conditions
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Mental Health Wellness 1

Intervention / Treatment
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* Dietary Supplement: Multi-Ingredient Herbal Supplement
* Dietary Supplement: Placebo Supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Mood Supplementation<br>The New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root. | Dietary Supplement: Multi-Ingredient Herbal Supplement<br>* 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.<br>|
| Placebo Comparator: Placebo Supplementation<br>The placebo includes rice bran and maltodextrin. | Dietary Supplement: Placebo Supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cortisol, mood