Onnit Labs New Mood Supplementation in Healthy College Students

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Dietary supplement: Multi-Ingredient Herbal Supplement; Dietary supplement: Placebo Supplement

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Moscow, Idaho, United States, 83844
      • University of Idaho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Mood Supplementation; The New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root.	Dietary supplement: Multi-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.
Placebo Comparator: Placebo Supplementation; The placebo includes rice bran and maltodextrin.	Dietary supplement: Placebo 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Idaho

Publications and helpful links

General Publications

• 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. 2022 May 30:1-12. doi: 10.1080/19390211.2022.2077880. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cortisol; mood
• Other Study ID Numbers: 18-138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No