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Stimulant

Extended-Release vs Immediate-Release Caffeine for Mood and Alertness

N/A
Recruiting
Research Sponsored by Applied Science & Performance Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 35-50 years
Be between 18 and 65 years old
Must not have
No history of anxiety disorders or sleep disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
Awards & highlights

Summary

This trial will test the differences between extended-release caffeine (ER-CAFF) and immediate-release caffeine (IR-CAFF) on side effects, mood, alertness, and cognitive abilities after a

Who is the study for?
This trial is for healthy men and women in the Tampa Bay Area who often have nights with less than 5 hours of sleep. They must be able to fast overnight and come to the lab twice, following a night of poor sleep confirmed by wearable devices.
What is being tested?
The study compares two types of caffeine: immediate-release (IR-CAFF) and extended-release (zümXR or ER-CAFF). Participants will take one type, undergo tests over several hours, then switch to the other type after at least a week.
What are the potential side effects?
Possible side effects may include jitteriness, increased heart rate, digestive discomfort, trouble sleeping if caffeine affects their rest later on, mood changes, or anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 35 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have never been diagnosed with anxiety or sleep disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Anxiousness using Visual Analog Scale (VAS)
Changes in Concentration using Visual Analog Scale (VAS)
Changes in Confidence using Visual Analog Scale (VAS)
+10 more
Secondary outcome measures
Changes in Positive & Negative Affect Schedule (PANAS)
Changes in Psychomotor Vigilance Test
Changes in Rapid Visual Information Processing
+1 more
Other outcome measures
Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental TreatmentExperimental Treatment1 Intervention
extended release xumXR caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg
Group II: Control TreatmentActive Control1 Intervention
immediate release caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg

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Who is running the clinical trial?

Applied Science & Performance InstituteLead Sponsor
12 Previous Clinical Trials
679 Total Patients Enrolled
~24 spots leftby Sep 2025
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