Changes in Metabolic Rate and Perceptual Indicators After Acute Ingestion of Paraxanthine
Condition: Metabolic Syndrome; Caffeine
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Venous Blood Collection; Resting Metabolic Rate Determination; Mood State; Visual Analog Scales
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Using a randomized, double-blind, placebo-controlled, crossover study design. 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.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: metabolic rate, paraxanthine, caffeine