Actively Recruiting
Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
Led by PLT Health Solutions · Updated on 2026-04-06
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male subjects aged >18 and <60 years.
- Experience episodic stress or situational anxiety at least once per week.
- Score at least 40 on a Visual Analog Scale for typical anxiety.
- Score at least 20 on the Positive Reactivity part of the Perth Emotional Reactivity Scale-Short Form.
- Able to complete surveys on the Alethios digital platform.
- Taking only stable doses of medications not used for anxiety.
- Generally in good health based on self-reported medical history and investigator opinion.
- Women of child-bearing potential agree to use medically approved birth control during the study.
- Agree to abstain from cannabis use during the study.
- Agree to maintain current diet and avoid calming supplements like ashwagandha, L-theanine, or St. John's Wort during the study.
- Aware of study procedures and willing to participate.
- Willing to sign informed eConsent according to regulations.
You will not qualify if you...
- Score above 9 on the Patient Health Questionnaire (PHQ-9) or any positive response on question 9 of PHQ-9.
- Score above 24 on the Hamilton Anxiety Scale (HAM-A).
- History of severe psychiatric or medical conditions interfering with participation.
- Consuming more than 14 alcoholic drinks per week.
- Regular cannabis use defined as two or more times per week in the past six weeks.
- History of drug abuse or dependence within the past six months.
- Medication changes within the past three months.
- Use of prescription medication for anxiety.
- Mental health diagnosis within the past three months.
- Unstable medical conditions.
- Known allergy to the study product.
- Pregnant, planning pregnancy, or breastfeeding.
- Unwillingness to use approved birth control if of child-bearing potential.
- Inability to meet digital study requirements.
- Participation in another clinical study within 30 days before randomization.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Alethios (Virtual)
San Francisco, California, United States, 94117
Actively Recruiting
Research Team
A
Alethios Support
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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