Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
250 (estimated)
Sponsor
PLT Health Solutions · Industry
Who this trial is looking for
This trial is looking for healthy adults who experience mild stress or anxiety episodes. Participants will take a dietary supplement or a placebo and report their feelings of anxiety after stressful situations over a few weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old.
I experience stress or anxiety at least once a week.
I usually feel at least somewhat anxious.
I am in generally good health.
I can complete surveys on a digital platform.
I will use a medically approved form of birth control if I can get pregnant.
I will not use cannabis during the study.
I will not use calming supplements during the study.
You may not be able to join if
I have had severe anxiety or depression recently.
I have a history of severe psychiatric conditions.
I regularly use cannabis.
I have abused drugs in the past 6 months.
I have had any medication changes in the last 3 months.
I take medications for anxiety.
I am pregnant, breastfeeding, or planning to become pregnant.
I cannot follow the digital study requirements.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this decentralized, two-arm, double-blinded, crossover clinical study is to test the efficacy of a supplement to reduce symptoms of acute stress or situational anxiety in healthy volunteers. The main questions it aims to answer are:
1. Does a dietary supplement reduce feelings of anxiety after self-identified episodes of stress or anxiety when compared to their experience after tak…
The purpose of this decentralized, two-arm, double-blinded, crossover clinical study is to test the efficacy of a supplement to reduce symptoms of acute stress or situational anxiety in healthy volunteers. The main questions it aims to answer are:
1. Does a dietary supplement reduce feelings of anxiety after self-identified episodes of stress or anxiety when compared to their experience after taking a placebo?
2. On a scale of 1-5, how much would the volunteer like to take the assigned treatment in the future?
3. Are any adverse events identified after either treatment, supplement, or placebo?
The study volunteers will:
During weeks 1-2, self-identify episodes of acute stress or situational anxiety and rate feelings of anxiety over the next five hours after taking the study product assigned for Period 1.
During week 3, volunteers will not take any study product nor complete any surveys.
During weeks 4-5, self-identify an episode of acute stress or situational anxiety and rate feelings of anxiety over the next five hours after taking the study product assigned for Period 2.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Female and male subjects aged \>18 and \<60 years.
2. Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
3. Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 re…
Inclusion Criteria:
1. Female and male subjects aged \>18 and \<60 years.
2. Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
3. Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents "extremely stressed or anxious."
4. Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
5. Ability to complete surveys on the Alethios digital platform.
6. Subject is only taking well-established, stable doses of prescription and non-prescription medications that are not indicated to treat anxiety disorder.
7. Subject is in generally good health as determined by a review of self-reported medical history and in the opinion of the Principal Investigator.
8. Women of child-bearing potential must agree to use a medically approved form of birth control during the study. Acceptable methods of birth control include hormonal - oral (pill), implantable, injectable (shot), ring, or transdermal (patch) contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; or an intra-uterine device (IUD.
9. Subject agrees to abstain from cannabis use for the duration of the study period
10. Subject agrees to maintain current dietary habits and abstain from using dietary supplements or herbal products thought to affect a sense of calming, including ashwagandha, L-theanine, or St. John's Wort, for the duration of the study period.
11. Individual is aware of the procedures and agrees to participate in the study.
12. Participant understands and is willing to sign an Informed eConsent in conformance with 21 CFR Part 50: "Protection of Human Participants."
Exclusion Criteria:
1. Score of \> 9 on the Patient Health Questionnaire (PHQ-9) or any response \> 0 on question 9 of the PHQ-9.
2. Score \> 24 on the Hamilton Anxiety Scale (HAM-A).
3. History of severe psychiatric or medical conditions that would interfere with participation.
4. Use of \>14 alcoholic drinks per week.
5. Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
6. Individuals with a history of drug abuse or dependence within the past 6 months.
7. Changes to medication treatment for any health condition within the prior 3 months.
8. Use of any prescription medication for anxiety.
9. Any diagnosis of a mental health condition in the prior 3 months.
10. Unstable medical conditions.
11. Known hypersensitivity to study product.
12. Participant is pregnant, planning to become pregnant, or breastfeeding.
13. Pregnant or lactating women or women of child-bearing potential unwilling to use a medically approved form of birth control.
14. Inability to comply with digital study requirements.
15. Participation in a clinical study within 30 days prior to randomization
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