NCT05811923|Completed
Changes in Metabolic Rate and Perceptual Indicators After Acute Ingestion of Paraxanthine
PX
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PX
Sponsor study identifier
interventional
20
1 country
1
Study Start
December 12, 2021
Actual (reported)Primary Completion
October 12, 2022
Actual (reported)Study Completion
October 12, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2022
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2021
Actual (reported)October 12, 2022
Actual (reported)October 12, 2022
Actual (reported)March 20, 2023
Actual (reported)April 13, 2023
Actual (reported)Rates of resting energy expenditure in response to supplement ingestion
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
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
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.
Rates of carbohydrate and fat oxidation in response to supplement ingestion
3 hours
Plasma concentrations of glycerol and free fatty acids after supplement ingestion
3 hours
Changes in resting heart rate in response to supplement ingestion.
3 hours
Changes in systolic blood pressure (mmHg) in response to supplement ingestion.
3 hours
Changes in diastolic blood pressure (mmHg) in response to supplement ingestion.
3 hours
Maltodextrin placebo capsules
200 mg caffeine capsules
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.
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301, United States
Chad M Kerksick, PhD
Lindenwood University
20 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2023
The January Application NUtritional Study (JANUS)
3 hours
100 mg paraxanthine capsules
200 mg paraxanthine capsules
300 mg paraxanthine capsules
200 mg caffeine + 200 mg paraxanthine capsules
200 mg 1-methylxanthine capsules
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.
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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First Posted
April 13, 2023
Study Start
December 12, 2021
Actual (reported)Primary Completion
October 12, 2022
Actual (reported)Study Completion
October 12, 2022
Actual (reported)Last Updated
April 13, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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