Changes in Metabolic Rate and Perceptual Indicators After Acute Ingestion of Paraxanthine (PX)

March 31, 2023 updated by: Lindenwood University
The purpose of this study is to evaluate the acute impact of ingesting individual and combined dosages of caffeine and paraxanthine in comparison to placebo on changes in resting metabolic rate, perceived levels of affect, and markers of lipolysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be conducted using a randomized, double-blind, placebo-controlled, crossover study design. Approximately 10 healthy men and 10 healthy women between the ages of 18 - 39 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a healthy history questionnaire to determine study eligibility. All participants will report to the laboratory for all study visits between 0600 - 1000 hours. Prior to each of the seven study visits, participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 24 hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be a screening visit where participants will first sign an IRB-approved informed consent document. To determine eligibility, participants will then complete a health and medical history form and have their height and weight assessed along with their resting heart rate and blood pressure. If determined eligible, study participants will allowed to exercise within 24 hours of each study visit. On one occasion prior to study visit 1, study participants will be required to record their food and fluid intake for the three days prior to each study visit and instructed to replicate this diet prior to each visit. To assist in replicating their food intake, participants will be given pre-packaged frozen meals of their choosing. All meals will provide similar amounts of energy, carbohydrates, fats, and proteins. Participants will be instructed to follow an overnight fast whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to each study visit. Water intake will be encouraged during this time for appropriate hydration status. Upon arrival for each subsequent study visit, participants will again have their body mass determined and they must be determined to be weight stable (defined as having a body mass within 2% of their previous study visit body mass). Resting heart rate, blood pressure, and body composition will then be assessed (only study visit 2) using a bio-electrical impedance analyzer (BIA). After assessment of body mass, resting heart rate, and resting blood pressure, study participants will donate their first of six venous blood samples. From there, participants will complete a series of assessments evaluating various perceptual indicators using the profile of mood states (POMS) and anchored 100-mm visual analog scales. Finally, participants will then have their resting metabolic rate determined using a metabolic cart. Upon determination of baseline resting metabolic rate, participants will be assigned in a randomized, double-blind, placebo-controlled, crossover fashion to ingest one of seven supplement conditions. One condition will be a non-energetic placebo (maltodextrin) while the other six supplemental conditions will be a 200 mg dose of caffeine, 100 mg paraxanthine, 200 mg paraxanthine, 300 mg paraxanthine, a combination of caffeine (200 mg) + paraxanthine (200 mg), and a 200 mg dose of 1-methylxanthine. All supplements will be orally ingested with 8 fluid ounces of cold tap water. The order of administration for all interventions will be randomized using a random allocation software to ensure randomization and to avoid order effects. After ingestion, participants will complete all assessments in an identical fashion 30, 60, 90, 120, and 180 minutes after ingestion of their assigned supplement. All study visits will take place between 0600 - 1000 hours. It is anticipated that follow-up study visits will be scheduled 3 - 7 days apart from each other after all dietary and exercise controls have been observed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Exercise and Performance Nutrition Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All participants will be between the ages of 18-39 years
  • Participants will be healthy and free of disease as determined by evaluation of a - medical history
  • All participants will be required to abstain from taking any additional forms of nutritional supplementation (pre-workouts, creatine, beta-alanine, thermogenic supplements, etc.) for four weeks prior to beginning this study and for the entire duration of the study
  • Participant's report accumulating at least 30 minutes of moderate exercise 3 days per week
  • Currently have a body mass index between 18.5 - 25 kg/m2. Alternatively, individuals with a body mass index between 25 - 30 kg/m2 will be included in the study if body-fat percentage is below 32% for females and 25% for males.
  • Not currently restricting calories or completing a dieting program
  • As determined through a caffeine intake survey, participants will be moderate caffeine consumers, consuming approximately 200 mg of caffeine per day.

Exclusion Criteria:

  • Those individuals less than 18 and greater than 40 years of age will be excluded. Participants younger than 18 are excluded due to necessity of parental consent. Participants greater than 40 years old are excluded due to the known changes that occur with metabolic rate as individuals achieve an age of 40 years or greater
  • As indicated on a self-reported medical history, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder or disease will be excluded.
  • Regular (>3 days/week) administration of thermogenic supplements or other weight loss aids in the past 60 days
  • Participants not meeting minimum exercise guidelines (30 minutes per day, 3 days per week) or exceeding 8 hours of exercise per week will be excluded
  • Daily intake of caffeine doses exceeding 300 mg/day
  • Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for 12 hours prior to each visit will be excluded
  • Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit will be excluded.
  • Participants who do not or are not willing to follow the prescribed dietary control leading up to each exercise bout will be excluded
  • Individuals who are pregnant, nursing, or trying to get pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Maltodextrin placebo capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).
Active Comparator: 200 mg caffeine
200 mg caffeine capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).
Experimental: 100 mg paraxanthine
100 mg paraxanthine capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).
Experimental: 200 mg paraxanthine
200 mg paraxanthine capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).
Experimental: 300 mg paraxanthine
300 mg paraxanthine capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).
Experimental: 200 mg caffeine + 200 mg paraxanthine
200 mg caffeine + 200 mg paraxanthine capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).
Experimental: 200 mg 1-methylxanthine
200 mg 1-methylxanthine capsules
Other: Venous Blood Collection
Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.
Other: Resting Metabolic Rate Determination
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.
Other: Mood State
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.
Other: Visual Analog Scales
Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of resting energy expenditure in response to supplement ingestion
Time Frame: 3 hours
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment. To complete each assessment, participants will rest supine with a blanket placed over them in an environment free of auditory and visual stimuli. A clear, hard plastic shield with a transparent plastic drape will be placed over the participant's head and shoulder and connected to the metabolic cart to collect all expired gases (oxygen and carbon dioxide). All expired gases will be analyzed using indirect calorimetry (TrueMax 2400 Metabolic Measurement System, ParvoMedics, Sandy, UT, USA) and computed to determine rates of energy expenditure
3 hours
Total energy expended over a 180-minute time period in response to supplement ingestion
Time Frame: 3 hours
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment. To complete each assessment, participants will rest supine with a blanket placed over them in an environment free of auditory and visual stimuli. A clear, hard plastic shield with a transparent plastic drape will be placed over the participant's head and shoulder and connected to the metabolic cart to collect all expired gases (oxygen and carbon dioxide). All expired gases will be analyzed using indirect calorimetry (TrueMax 2400 Metabolic Measurement System, ParvoMedics, Sandy, UT, USA) and computed to determine rates of energy expenditure
3 hours
Perceptual responses of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger and confidence, hunger, and appetite
Time Frame: 3 hours
Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire and visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. 0 is lowest level and 5 is highest level.
3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of carbohydrate and fat oxidation in response to supplement ingestion
Time Frame: 3 hours
During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment. To complete each assessment, participants will rest supine with a blanket placed over them in an environment free of auditory and visual stimuli. A clear, hard plastic shield with a transparent plastic drape will be placed over the participant's head and shoulder and connected to the metabolic cart to collect all expired gases (oxygen and carbon dioxide). All expired gases will be analyzed using indirect calorimetry (TrueMax 2400 Metabolic Measurement System, ParvoMedics, Sandy, UT, USA) and computed to determine rates of carbohydrate and fat oxidation in response to supplement ingestion
3 hours
Plasma concentrations of glycerol and free fatty acids after supplement ingestion
Time Frame: 3 hours
The collected blood will be analyzed using a hand-held glucose analyzer and fasting will be considered confirmed if glucose is < 110 mg/dL. Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent
3 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in resting heart rate in response to supplement ingestion.
Time Frame: 3 hours
Resting heart rate (bpm) measured at all 6 time points over 180 minutes
3 hours
Changes in systolic blood pressure (mmHg) in response to supplement ingestion.
Time Frame: 3 hours
Systolic blood pressure (mmHg) are measured at all 6 time points across 180 minutes
3 hours
Changes in diastolic blood pressure (mmHg) in response to supplement ingestion.
Time Frame: 3 hours
Diastolic blood pressure (mmHg) are measured at all 6 time points across 180 minutes
3 hours
Changes in adverse events
Time Frame: 3 hours
Adverse events are self-reported at all study visits and all time-points
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lindenwood University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chad M Kerksick, PhD, Lindenwood University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-22-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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