Skip to main content
OpenTrials
Completed

NCT Number: NCT05109923

Onnit Labs New Mood Supplementation in Healthy College Students

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental Health Wellness 1

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Idaho

Moscow, Idaho, 83844, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Ingredient Herbal Supplement

Dietary 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

Dietary 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.

Primary outcomes

  1. Change in cortisol awakening response (mg/dL) over 8 weeks

    Time frame: 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

  2. Change in resting heart rate (beats per minute) over 8 weeks

    Time frame: 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

  3. Change in resting systolic and diastolic blood pressure (mm Hg) over 8 weeks

    Time frame: 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

  4. Change in depression, anxiety and stress scores (0-34) over 8 weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Idaho

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.