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Onnit Labs New Mood Supplementation in Healthy College Students

NCT ID: NCT05109923

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Health Wellness 1

Keywords

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cortisol mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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New Mood Supplementation

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

Group Type EXPERIMENTAL

Multi-Ingredient Herbal Supplement

Intervention Type 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 Supplementation

The placebo includes rice bran and maltodextrin.

Group Type PLACEBO_COMPARATOR

Placebo Supplement

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Idaho

OTHER

Sponsor Role lead

Responsible Party

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Ann Brown

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Idaho

Moscow, Idaho, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35635482 (View on PubMed)

Other Identifiers

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18-138

Identifier Type: -

Identifier Source: org_study_id