Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine

NCT06441695 | Completed

• 1 other identifier: Pro00078903
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a (2 visit) double-blind, randomized, crossover design clinical study to assess the potential benefits of ER-CAFF versus IR-CAFF by assessing its impact on side effect profiles, mood states, alertness, and cognitive abilities following ingestion after a suboptimal night of sleep. This study will enroll 30 healthy men and women who will be recruited by word of mouth, email contact, and direct contact from the greater Tampa Bay Area. To account for potential dropouts, we aim to enroll approximately 20% over the desired sample size (total of 36 participants). The anticipated study period will last approximately 2 weeks. After initial pre-screening, participants will report to the laboratory on two separate occasions after an overnight fast (10 hours minimum). Participants will be required to have a night of partial sleep deprivation the night before (\<5 hours sleep), which will be confirmed by self reported sleep logs and objective multisensor (triaxial accelerometry and cardiac data) wearable devices to accurately measure sleep deficit data. Upon arrival, participants will undergo baseline (BL) testing and then ingest a bolus of one study product with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine anhydrous (IR-CAFF) (2 group, crossover design). Thereafter, participants will undergo subsequent testing sessions at 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. After the 4-hour (240 min) measurements, a caffeine-free food bar will be provided. This same food bar will also be offered to participants following the final 7-hour (420 min) measurements. The precise measures and timepoints for the measures are further defined below. There will be a one-week minimum washout period between treatments in the crossover design.

Conditions

Caffeine; Cognitive Change; Mood; Mood Change

Keywords

extended release caffeine; caffeine

Outcome Measures

Primary Outcomes (13)

• Changes in Concentration using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Higher values indicate greater alertness and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Energy using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Higher values indicate greater energy and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Confidence using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Higher values indicate greater energy and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Mood Enhancement using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Higher values indicate greater mood enhancements and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Jitteriness using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Lower values indicate less jitters and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Anxiousness using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Lower values indicate less jitters and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Sleepy using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Lower values indicate less jitters and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Irritability using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Lower values indicate less jitters and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Heart Rate (Heart Pounding) using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Lower values indicate less jitters and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Changes in Headache using Visual Analog Scale (VAS)

  The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. Scoring is from 0 (no effect) to 100 (extremely high effect). Lower values indicate less jitters and is considered to be a better outcome.

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

• Heart rate (HR)

  Changes in heart rate post supplementation; resting HR measured using pulse oximeter

  baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation

• Diastolic blood pressure (BP)

  Changes in diastolic BP post supplementation. Resting blood pressure measured using an automated BP cuff.

  baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation

• Systolic blood pressure (BP)

  Changes in systolic BP post supplementation. Resting blood pressure measured using an automated BP cuff.

  baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation

Secondary Outcomes (4)

• Changes in Rapid Visual Information Processing

  baseline , 90 and 300 minutes post-supplementation.

• Changes in Psychomotor Vigilance Test

  baseline , 90 and 300 minutes post-supplementation.

• Changes in Samn-Perelli/Thayer's scale (aka Stanford Sleepiness Scale)

  baseline, 90, 300, and 420 minutes post-supplementation.

• Changes in Positive & Negative Affect Schedule (PANAS)

  baseline, 90, 300, and 420 minutes post-supplementation.

Other Outcomes (1)

• Adverse Events

  baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation.

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

extended release xumXR caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg

Dietary Supplement: xumXR extended release caffeine

Control Treatment

ACTIVE COMPARATOR

immediate release caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg

Dietary Supplement: immediate release caffeine

Interventions

xumXR extended release caffeine DIETARY_SUPPLEMENT

proprietary capsule for extended release of caffeine

Experimental Treatment

immediate release caffeine DIETARY_SUPPLEMENT

immediate release caffeine capsule

Control Treatment

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 35-50 years (both limits inclusive);
• Body mass index (BMI) of 18.50-29.99 kg/m2 -Habitual moderate caffeine consumers (200-400 mg/day) assessed through caffeine assessment tool (Caffeine -
• Consumption Questionnaire, CCQ);
• Intermediate chronotype (\>31 or \<69 on Morningness-Eveningness Questionnaire).

You may not qualify if:

• Subjects presenting any of the following will not be included in the study:
• No history of anxiety disorders or sleep disorders;
• Non-smokers;
• Alcohol consumption 72 hours prior to the start of study/consumption of study product;
• No use of sleep medicines, melatonin, marijuana within two weeks of start of study;
• No travel involving time zone change, shift work, or other life events that alter sleep schedule \>3 hours from the norm one week before the start of study (assessed using sleep-wake schedule diary for week prior to study);
• Caffeine restricted past 12 PM from the day prior to the start of study (verify through caffeine diet history).

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science & Performance Institute

Tampa, Florida, 33634, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: June 13, 2024
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)