Mental Health Wellness 1NCT05109923
Onnit Labs New Mood Supplementation in Healthy College Students
A study testing Multi-Ingredient Herbal Supplement in people with Mental Health Wellness 1, run by University of Idaho at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Multi-Ingredient Herbal Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 2 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently enrolled collegiate men and women at the University of Idaho
Who cannot join
- Currently taking mood or sleep enhancing supplementation/medication
- Currently participating in counseling and/or therapy sessions
- Previously diagnosed with a psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Onnit New Mood Supplementation in Healthy Collegiate Men and Women
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
- Being tested
- Multi-Ingredient Herbal Supplement, Placebo Supplement
- Keywords
- cortisol, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Ingredient Herbal SupplementDietary 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 SupplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| New Mood Supplementation | Experimental | The New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root. Receives: Dietary Supplement: Multi-Ingredient Herbal Supplement |
| Placebo Supplementation | Placebo comparator | The placebo includes rice bran and maltodextrin. Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline DASS-21 score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start10 Sep 2018
- Primary completion3 May 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Brown, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109923
- Sponsor's protocol ID
- 18-138
- Status last verified
- Oct 2021
- First submitted
- 10 Dec 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35635482
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Onnit New Mood Supplementation in Healthy Collegiate Men and Women
- ClinicalTrials.gov ID
- NCT05109923
- Acronym / sponsor ID
- 18-138
- Conditions
- Mental Health Wellness 1
- Keywords
- cortisol, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Mood Supplementation | Experimental | Dietary Supplement: Multi-Ingredient Herbal SupplementThe New Mood herbal supplement includes lemon balm, 5-HPT, L-Tryptophan and valerian root. |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: Placebo SupplementThe placebo includes rice bran and maltodextrin. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Currently enrolled collegiate men and women at the University of Idaho
Key exclusion criteria (3 listed)
- Currently taking mood or sleep enhancing supplementation/medication
- Currently participating in counseling and/or therapy sessions
- Previously diagnosed with a psychological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Ingredient Herbal SupplementWeeks 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. | Dietary supplement | New Mood Supplementation |
| Placebo SupplementWeeks 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. | Dietary supplement | Placebo Supplementation |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Derived from this study: PubMed 35635482Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Ingredient Herbal Supplement in people with Mental Health Wellness 1, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortisol awakening response (mg/dL) over 8 weeks (time frame: Change from baseline cortisol awakening response (mg/dL) at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.