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

Official title

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

Overview

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.

Interventions

• Dietary supplement Botanical extract for anxiety
  Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day.
• Dietary supplement Placebo capsule
  Capsule containing inert excipients only

Primary outcome measures

• Visual Analog Scale Score [Time frame: 30 minutes after intervention administration]
• Visual Analog Scale Score [Time frame: 60 minutes after intervention administration]
• Visual Analog Scale Score [Time frame: 120 minutes after intervention administration]

Secondary outcome measures (1)

• Adverse Events [Time frame: Throughout study completion, an average of 35 days]

Eligibility criteria

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.
• 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.
• Subject agrees to abstain from cannabis use for the duration of the study period
• 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.
• Individual is aware of the procedures and agrees to participate in the study.
• Participant understands and is willing to sign an Informed eConsent in conformance with 21 CFR Part 50: "Protection of Human Participants."

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.
• Use of any prescription medication for anxiety.
• Any diagnosis of a mental health condition in the prior 3 months.
• Unstable medical conditions.
• Known hypersensitivity to study product.
• Participant is pregnant, planning to become pregnant, or breastfeeding.
• Pregnant or lactating women or women of child-bearing potential unwilling to use a medically approved form of birth control.
• Inability to comply with digital study requirements.
• Participation in a clinical study within 30 days prior to randomization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Alethios (Virtual) — San Francisco

Identifiers

NCT: NCT07511088 · PLT002_SSA26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗