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

Overseen By Alethios Support

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: PLT Health Solutions

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Dawna Salter-Farfan, PhD, RD

Principal Investigator

PLT Health Solutions

Are You a Good Fit for This Trial?

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."

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Dietary Supplement Active Control 1 Intervention

A 25 mg dose of a standardized extract from the aerial parts of Sceletium tortuosum, delivered by mouth as needed once per day.

Group II: Placebo Placebo Group 1 Intervention

A capsule containing only excipients matched in appearance and size to active comparator.

Who Is Running the Clinical Trial?

PLT Health Solutions

Lead Sponsor