Dietary supplement for brief episodes of situational anxiety in healthy adults

A Decentralized Study Utilizing Non-invasive Measures to Evaluate a Botanical Supplement on Episodes of Mild Acute Stress and Situational Anxiety

This trial will test whether a botanical dietary supplement reduces feelings of acute situational anxiety in healthy adults who commonly experience brief episodes of stress.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: PLT Health Solutions (Industry-sponsored)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07511088 on ClinicalTrials.gov

What this trial studies

This is a decentralized, two-arm, double-blinded crossover trial comparing a botanical extract capsule with a matched placebo in healthy adults who experience episodic situational anxiety. Participants self-identify episodes of acute stress, take the assigned product, and rate their anxiety over the next five hours during two separate treatment periods (weeks 1-2 and weeks 4-5) separated by a one-week washout (week 3). The study compares within-person anxiety ratings after supplement versus placebo and asks how likely participants would be to use the assigned product again, while also collecting any adverse events. All data are collected remotely through the Alethios digital platform and participants must meet baseline criteria including age 18-59 and at least weekly episodic stress.

Who should consider this trial

Good fit: Ideal candidates are generally healthy adults aged 18-59 who experience situational anxiety at least once per week, can use the Alethios digital platform, and are not taking medications specifically for anxiety.

Not a fit: People with diagnosed anxiety disorders, those taking medications for anxiety, or those outside the age range may not benefit from results of this study.

Why it matters

Potential benefit: If effective, the supplement could provide a fast-acting, over-the-counter option to lessen feelings of acute situational anxiety for some people.

How similar studies have performed: Previous trials of botanical supplements for anxiety have shown mixed and modest benefits, so this approach has some precedent but is not definitively proven.

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 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

Where this trial is running

San Francisco, California

• Alethios (Virtual) — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Dawna Salter-Farfan, PhD, RD — PLT Health Solutions
• Study coordinator: Alethios Support

Conditions Situational Anxiety; situational anxiety; acute stress; dietary supplement; decentralized study