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

NCT07511088 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Situational Anxiety

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

Sponsors & Collaborators

  • PLT Health Solutions

    lead INDUSTRY

Principal Investigators

  • Dawna Salter-Farfan, PhD, RD · PLT Health Solutions

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2026-06-15
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511088 on ClinicalTrials.gov