Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People

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

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.

Study Overview

• Status: Recruiting
• Conditions: Situational Anxiety
• Intervention / Treatment: Dietary supplement: Botanical extract for anxiety; Dietary supplement: Placebo capsule

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alethios Support; Phone Number: 620-206-8006; Email: support@alethios.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94117
      • Recruiting
      • Alethios (Virtual)
      • Contact: Alethios Support; Phone Number: 650-206-8006; Email: support@alethios.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary Supplement; A 25 mg dose of a standardized extract from the aerial parts of Sceletium tortuosum, delivered by mouth as needed once per day.	Dietary supplement: Botanical extract for anxiety; Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day.
Placebo Comparator: Placebo; A capsule containing only excipients matched in appearance and size to active comparator.	Dietary supplement: Placebo capsule; Capsule containing inert excipients only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Score	Change in anxiety VAS score	30 minutes after intervention administration
Visual Analog Scale Score	Change in anxiety VAS score	60 minutes after intervention administration
Visual Analog Scale Score	Change in anxiety VAS score	120 minutes after intervention administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Tolerance	Throughout study completion, an average of 35 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Treatment Arm Survey	Satisfaction/desire to take intervention again	Day 14 and Day 35

Collaborators and Investigators

• Sponsor: PLT Health Solutions
• Investigators: Principal Investigator: Dawna Salter-Farfan, PhD, RD, PLT Health Solutions

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: dietary supplement; acute stress; situational anxiety; decentralized study
• Other Study ID Numbers: PLT002_SSA26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No