Onnit Labs New Mood Supplementation in Healthy College Students

Mental Health Wellness 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109923
• Other study ID #: 18-138
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: October 2021
• Source: University of Idaho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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 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.

Locations

Country	Name	City	State
United States	University of Idaho	Moscow	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
University of Idaho

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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