Onnit Labs New Mood Supplementation in Healthy College Students

Not Applicable

Completed

• Conditions: Mental Health Wellness 1
• Interventions: Dietary Supplement: Multi-Ingredient Herbal Supplement; Dietary Supplement: Placebo Supplement

• Registration Number: NCT05109923
• Lead Sponsor: University of Idaho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-10
• Primary Completion: 2019-05-03
• Study Completion: 2019-08-02
• Study First Submitted: 2020-12-10
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Mood Supplementation	Multi-Ingredient Herbal Supplement	The New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root.
Placebo Supplementation	Placebo Supplement	The placebo includes rice bran and maltodextrin.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Idaho; 🇺🇸 Moscow, Idaho, United States