CompletedNot Applicable

Onnit Labs New Mood Supplementation in Healthy College Students

United States56 participantsStarted 2018-09-10

Plain-language 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.

Who can participate

Age range

18 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Change from baseline cortisol awakening response (mg/dL) at 8 weeks

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

Timeframe: 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

Timeframe: 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

Timeframe: Change from baseline DASS-21 score at 8 weeks

Trial details

NCT IDNCT05109923

SponsorUniversity of Idaho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-03

View on ClinicalTrials.gov More Mental Health Wellness 1 trials