Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy… (NCT07511088) | Clinical Trial Compass
RecruitingNot Applicable
Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
United States250 participantsStarted 2026-01-29
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 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
. Female and male subjects aged \>18 and \<60 years.
. Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
. 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."
. Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
. Ability to complete surveys on the Alethios digital platform.
. Subject is only taking well-established, stable doses of prescription and non-prescription medications that are not indicated to treat anxiety 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
1
Visual Analog Scale Score
Timeframe: 30 minutes after intervention administration
2
Visual Analog Scale Score
Timeframe: 60 minutes after intervention administration
3
Visual Analog Scale Score
Timeframe: 120 minutes after intervention administration
. Subject is in generally good health as determined by a review of self-reported medical history and in the opinion of the Principal Investigator.
. 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.
Exclusion criteria
. Score of \> 9 on the Patient Health Questionnaire (PHQ-9) or any response \> 0 on question 9 of the PHQ-9.
. Score \> 24 on the Hamilton Anxiety Scale (HAM-A).
. History of severe psychiatric or medical conditions that would interfere with participation.
. Use of \>14 alcoholic drinks per week.
. Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
. Individuals with a history of drug abuse or dependence within the past 6 months.
. Changes to medication treatment for any health condition within the prior 3 months.