Onnit Labs New Mood Supplementation in Healthy College Students

NCT05109923 | Completed

• 1 other identifier: 18-138
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Wellness 1

Keywords

cortisol; mood

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

New Mood Supplementation

EXPERIMENTAL

The New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root.

Dietary Supplement: Multi-Ingredient Herbal Supplement

Placebo Supplementation

PLACEBO COMPARATOR

The placebo includes rice bran and maltodextrin.

Dietary Supplement: Placebo Supplement

Interventions

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.

New Mood Supplementation

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.

Placebo Supplementation

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently enrolled collegiate men and women at the University of Idaho

You may not qualify if:

• Currently taking mood or sleep enhancing supplementation/medication
• Currently participating in counseling and/or therapy sessions
• Previously diagnosed with a psychological disorder

Sponsors & Collaborators

• University of Idaho: lead

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844, United States

Location

Related Publications (1)

• 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. 2023;20(4):631-642. doi: 10.1080/19390211.2022.2077880. Epub 2022 May 30.

  PMID: 35635482 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: November 5, 2021
• Study Start: September 10, 2018
• Primary Completion: May 3, 2019
• Study Completion: August 2, 2019
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)