Metabolic SyndromePXNCT05811923
Changes in Metabolic Rate and Perceptual Indicators After Acute Ingestion of Paraxanthine
A study testing Venous Blood Collection, Resting Metabolic Rate Determination and Mood State in people with Metabolic Syndrome and Caffeine, run by Lindenwood University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Caffeine
- What is being tested?
- Venous Blood Collection, Resting Metabolic Rate Determination and Mood State
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2021to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Caffeine
- Being tested
- Venous Blood Collection, Resting Metabolic Rate Determination, Mood State, Visual Analog Scales
- Keywords
- metabolic rate, paraxanthine, caffeine
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Blood CollectionOther
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.
Resting Metabolic Rate DeterminationOther
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.
Mood StateOther
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.
Visual Analog ScalesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin placebo capsules Receives: 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 Receives: Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales |
| 100 mg paraxanthine | Experimental | 100 mg paraxanthine capsules Receives: Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales |
| 200 mg paraxanthine | Experimental | 200 mg paraxanthine capsules Receives: Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales |
| 300 mg paraxanthine | Experimental | 300 mg paraxanthine capsules Receives: 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 Receives: 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 Receives: Other: Venous Blood Collection; Other: Resting Metabolic Rate Determination; Other: Mood State; Other: Visual Analog Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 3 hours
Secondary outcomes (2)
Rates of carbohydrate and fat oxidation 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 carbohydrate and fat oxidation in response to supplement ingestion
Measured: 3 hours
Plasma concentrations of glycerol and free fatty acids after supplement ingestion
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
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start12 Dec 2021
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811923
- Sponsor's protocol ID
- IRB-22-30
- Acronym
- PX
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Metabolic Rate and Perceptual Indicators After Acute Ingestion of Paraxanthine
- ClinicalTrials.gov ID
- NCT05811923
- Acronym / sponsor ID
- PX / IRB-22-30
- Conditions
- Metabolic Syndrome, Caffeine
- Keywords
- metabolic rate, paraxanthine, caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog ScalesMaltodextrin placebo capsules |
| 200 mg caffeine | Active comparator | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog Scales200 mg caffeine capsules |
| 100 mg paraxanthine | Experimental | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog Scales100 mg paraxanthine capsules |
| 200 mg paraxanthine | Experimental | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog Scales200 mg paraxanthine capsules |
| 300 mg paraxanthine | Experimental | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog Scales300 mg paraxanthine capsules |
| 200 mg caffeine + 200 mg paraxanthine | Experimental | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog Scales200 mg caffeine + 200 mg paraxanthine capsules |
| 200 mg 1-methylxanthine | Experimental | Other: Venous Blood Collection, Other: Resting Metabolic Rate Determination, Other: Mood State, Other: Visual Analog Scales200 mg 1-methylxanthine capsules |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous Blood CollectionWithin 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 | 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 DeterminationDuring 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 | 100 mg paraxanthine, 200 mg 1-methylxanthine, 200 mg caffeine, 200 mg caffeine + 200 mg paraxanthine, 200 mg paraxanthine, 300 mg paraxanthine, Placebo |
| Mood StateParticipants 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 | 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 ScalesParticipants 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). | Other | 100 mg paraxanthine, 200 mg 1-methylxanthine, 200 mg caffeine, 200 mg caffeine + 200 mg paraxanthine, 200 mg paraxanthine, 300 mg paraxanthine, Placebo |
Primary outcome
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
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
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.
2 secondary outcomes
Rates of carbohydrate and fat oxidation in response to supplement ingestion
Time frame: 3 hours
Plasma concentrations of glycerol and free fatty acids after supplement ingestion
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous Blood Collection, Resting Metabolic Rate Determination and Mood State in people with Metabolic Syndrome and Caffeine, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of resting energy expenditure in response to supplement ingestion (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.