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

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