Onnit Labs New Mood Supplementation in Healthy College Students

University of Idaho56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Mental Health Wellness 1

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from baseline DASS-21 score at 8 weeks