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

NCT05811923 | Completed

• 1 other identifier: IRB-22-30
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Caffeine

Keywords

metabolic rate, paraxanthine, caffeine

Outcome Measures

Primary Outcomes (3)

• 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.

  3 hours

Secondary Outcomes (2)

• 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

Other Outcomes (4)

• 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

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Maltodextrin placebo capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

200 mg caffeine

ACTIVE COMPARATOR

200 mg caffeine capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

100 mg paraxanthine

EXPERIMENTAL

100 mg paraxanthine capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

200 mg paraxanthine

EXPERIMENTAL

200 mg paraxanthine capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

300 mg paraxanthine

EXPERIMENTAL

300 mg paraxanthine capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

200 mg caffeine + 200 mg paraxanthine

EXPERIMENTAL

200 mg caffeine + 200 mg paraxanthine capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

200 mg 1-methylxanthine

EXPERIMENTAL

200 mg 1-methylxanthine capsules

Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales

Interventions

Venous Blood Collection OTHER

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.

100 mg paraxanthine; 200 mg 1-methylxanthine; 200 mg caffeine; 200 mg caffeine + 200 mg paraxanthine; 200 mg paraxanthine; 300 mg paraxanthine; Placebo

Resting Metabolic Rate Determination OTHER

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.

100 mg paraxanthine; 200 mg 1-methylxanthine; 200 mg caffeine; 200 mg caffeine + 200 mg paraxanthine; 200 mg paraxanthine; 300 mg paraxanthine; Placebo

Mood State OTHER

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.

100 mg paraxanthine; 200 mg 1-methylxanthine; 200 mg caffeine; 200 mg caffeine + 200 mg paraxanthine; 200 mg paraxanthine; 300 mg paraxanthine; Placebo

Visual Analog Scales OTHER

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).

100 mg paraxanthine; 200 mg 1-methylxanthine; 200 mg caffeine; 200 mg caffeine + 200 mg paraxanthine; 200 mg paraxanthine; 300 mg paraxanthine; Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All supplements provided to all research participants containing Caffeine, Paraxanthine, 1-Methylxanthine, or Placebo will be procured and prepared in a similar manner. All supplements are in identical capsules.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 13, 2023
• Study Start: December 12, 2021
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)