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Active for Stress

N/A
Recruiting
Led By Andrew Swick, PhD
Research Sponsored by Supplement Formulators, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory, male or female, 21-65 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial tests a theanine supplement to see if it can reduce stress, burnout, improve mood, and improve sleep.

Who is the study for?
This trial is for English-speaking adults aged 21-65 with a BMI of 18.5-34.9 who experience moderate to severe stress occasionally, as indicated by a PSS-14 score >19. Participants must be generally healthy, not taking certain supplements or drugs affecting stress and sleep, able to operate smart devices, and willing to follow the study's diet and activity guidelines.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a Theanine-based formulation against a placebo in reducing stress levels. It aims to see if this supplement can improve mood, reduce burnout symptoms, and enhance sleep quality among those who report occasional high levels of stress.See study design
What are the potential side effects?
While specific side effects are not listed for Theanine, potential reactions could include digestive discomfort or allergic responses. As it's being compared with a placebo which typically has no active ingredients, any side effects from the actual supplement should be noticeable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 65 years old and can walk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Perceived Stress Scale (PSS-14)
State-Trait Anxiety Inventory (STAI)
Secondary outcome measures
Cortisol Levels
Depression, Anxiety and Stress Scale-21 (DASS-21)
Leeds Sleep Evaluation Questionnaire (LSEQ)
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Dietary Supplement: Theanine for stress relief formulation
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet

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Who is running the clinical trial?

Supplement Formulators, Inc.Lead Sponsor
12 Previous Clinical Trials
363 Total Patients Enrolled
Andrew Swick, PhDPrincipal InvestigatorLife Extension
1 Previous Clinical Trials
79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participants being accepted for this trial at present?

"This clinical trial, which was first put on record February 9th 2023, is currently recruiting participants. Its details have most recently been changed on May 2nd 2023 according to the information available through clinicaltrials.gov."

Answered by AI

How many participants may join this clinical investigation?

"Affirmative. Clinicaltrials.gov data points to this clinical trial actively searching for patients, which was first published on February 9th of 2023 and recently updated on May 2nd of the same year. The study requires 104 individuals across one medical site for successful completion."

Answered by AI

Who is eligible to participate in this experiment?

"To qualify for the study, potential participants must be in the 21 to 65 age bracket and currently be experiencing stress. 104 candidates are required in total."

Answered by AI

Are participants of any age welcome in this trial?

"The eligibility requirements of this clinical study limit the age range to between 21 and 65 years old. There are 23 trials specifically designed for minors, while 110 studies focus on adults over 65."

Answered by AI

What objectives are researchers attempting to accomplish with this undertaking?

"This 28-day clinical trial will assess the State-Trait Anxiety Inventory (STAI). Secondary objectives include evaluating changes in sleep quality via the Leeds Sleep Evaluation Questionnaire (LSEQ) which scores from 0 to 100, assessing emotional exhaustion and depersonalization using a Maslach Burnout Inventory (MBI-GS), as well as quantifying general health perceptions with Short Form -36 Health Survey (SF-36)."

Answered by AI
Recent research and studies
~13 spots leftby Jun 2024