Fatigue; Muscle, HeartNCT06529055
Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
A study testing Oral Pouch - Nicotine and Oral Pouch - Caffeine in people with Fatigue; Muscle, Heart and Fatigue, Mental, run by University of Southern Mississippi at 1 site in United States.
Trial summary
The goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue; Muscle, Heart, Fatigue, Mental
- What is being tested?
- Oral Pouch - Nicotine and Oral Pouch - Caffeine
- 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
- 30 Jul 2024to 31 Dec 2024
- 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 21 to 40 years of age
- Being biologically male
- Having a body mass index (BMI) of < 30 kilograms/meter-squared
- Participating in moderate/vigorous exercise for at least 150 minutes/week over the last month
Who cannot join
- individuals who are younger than 21 or older than 40
- missing any limbs or part of a limb
- having any neuromuscular/musculoskeletal injury or impairment that would prevent performing any exercise/functional measures for this study
- having a pacemaker or any other electrical implant
- a diagnosis (defined as the presence of disease of or using medication to treat the disease) of heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease, type I or type II diabetes
- taking insulin injections
Show all 17Show fewer
- any history of severe or mild traumatic brain injury within the last two years
- kidney, liver, thyroid, or heart disease
- treated or untreated American Heart Association stage 2 hypertension (>140 millimeters of mercury / > 90 millimeters of mercury)
- any diagnosed neurological or neurodegenerative diseases
- having donated blood or plasma in the last 20 days prior to blood collection procedures
- taking any supplements/medications that may interfere with the results of the study
- any surgeries that would impact swallowing and/or digestion
- currently smoking, vaping, using e-cigarettes, or using any other combustible/smokeless tobacco products
- using smokeless tobacco-free nicotine products on more than 2 days/week
- daily caffeine use of more than 250 milligrams/day or use of any oral caffeine pouches
- have allergies or are regularly taking medications that would impact this study and/or negatively interact with caffeine or nicotine.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern Mississippi - School of Kinesiology and Nutrition
Hattiesburg, Mississippi, 39406
About this study
The goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40.
Accordingly, the primary aims of the study are to determine the effects of acute oral nicotine pouches, oral caffeine pouches, or both, on measures of
Read more
- anaerobic performance
- cognition
- cardiovascular and autonomic function
- appetite and food intake.
Researchers will compare oral nicotine pouches, oral caffeine pouches, both oral nicotine and caffeine pouches, and a flavor and color matched placebo to see if how they differentially affect measurements of
- physical performance,
- cognition,
- cardiovascular and autonomic function
- appetite and food intake.
On four separate occasions, participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling, cognitive, and balance tests while blood and salivary biomarkers, subjective appetite ratings, and cardiovascular and autonomic function measurements are collected. After each trial, participants will complete a 24-hr food record.
- Conditions
- Fatigue; Muscle, Heart, Fatigue, Mental
- Being tested
- Oral Pouch - Nicotine, Oral Pouch - Caffeine, Oral Pouch - Placebo
- Medical subject headings
- Fatigue, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Pouch - NicotineOther
Ingestion of a randomized oral nicotine pouch
Oral Pouch - CaffeineOther
Ingestion of a randomized oral caffeine pouch
Oral Pouch - PlaceboOther
Ingestion of a randomized oral placebo pouch
| Study group | Role | What they receive |
|---|---|---|
| Oral Nicotine Pouches | Experimental | Single dose 3mg oral nicotine pouch Receives: Other: Oral Pouch - Nicotine |
| Oral Caffeine Pouches | Experimental | Single dose 100mg oral caffeine pouch Receives: Other: Oral Pouch - Caffeine |
| Combination of oral nicotine and caffeine pouches | Experimental | Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch Receives: Other: Oral Pouch - Nicotine; Other: Oral Pouch - Caffeine |
| Placebo | Placebo comparator | Flavor, color, and appearance matched placebo Receives: Other: Oral Pouch - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wingate Anaerobic Cycling Test
Changes in anaerobic cycling power output
Measured: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Concentration of blood lactate
Changes in blood lactate concentration from capillary blood
Measured: Baseline, 25, 32 minutes post-ingestion
Concentration of salivary cortisol
Changes in salivary cortisol concentration from saliva
Measured: Baseline, 15, 25, 32 minutes post-ingestion
Concentration of salivary interleukin-6
Changes in interleukin-6 concentration from saliva
Measured: Baseline, 15, 25, 32 minutes post-ingestion
Salivary catecholamine concentration
Changes in salivary catecholamine concentration from saliva
Measured: Baseline, 15, 27, 40 minutes post-ingestion
Profile of Mood States
Changes in Profile of Mood States scores (Score range: 0-60)
Measured: Baseline, 15, 32 minutes post-ingestion
Balance
Changes in standing postural sway
Measured: Baseline, 15, 32 minutes post-ingestion
Ratings of perceived exertion
Changes in ratings of perceived exertion (Scale range: 6-20 - lower ratings means less effort))
Measured: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Hunger - Visual Digital Analog Scale (0-100)
Changes in subjective ratings of hunger
Measured: Baseline, 15, 25, 32 minutes post-ingestion
Desire to eat - Visual Digital Analog Scale (0-100)
Changes in subjective ratings of desire to eat
Measured: Baseline, 15, 25, 32, 60 minutes post-ingestion
Prospective Consumption of Food - Visual Digital Analog Scale (0-100)
Changes in subjective ratings of prospective consumption of food
Measured: Baseline, 15, 25, 32, 60 minutes post-ingestion
Fullness - Visual Digital Analog Scale (0-100)
Changes in subjective ratings of fullness
Measured: Baseline, 15, 25, 32, 60 minutes post-ingestion
Food Intake - Digital 24-hour food record
Consumption of food and beverage after study visit
Measured: 24 hours following the end of each visit
Blood Pressure
Absolute brachial blood pressure values (systolic and diastolic) and relative changes from baseline.
Measured: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Heart Rate
Absolute heart rate values and relative changes from baseline.
Measured: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Trail Making Test - Digital Cognitive Function Test
Changes in trail making test scores
Measured: Baseline, 15, 32 minutes post-ingestion
Sustained Attention Test - Digital Cognitive Function Test
Changes in sustained attention test scores
Measured: Baseline, 15, 32 minutes post-ingestion
Visual Working Memory Span Test - Digital Cognitive Function Test
Changes in visual working memory span test scores
Measured: Baseline, 15, 32 minutes post-ingestion
Stroop Test - Digital Cognitive Function Test
Changes in Stroop test scores
Measured: Baseline, 15, 32 minutes post-ingestion
Deary-Liewald Test - Digital Cognitive Function Test
Changes in Deary-Liewald test scores
Measured: Baseline, 15, 32 minutes post-ingestion
Cerebral Blood flow
Doppler ultrasound derived blood flow in the carotid artery
Measured: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Secondary outcomes (6)
Blood Glucose Concentration
Changes in blood glucose concentration from capillary blood
Measured: Baseline, 15, 25, 32 minutes post-ingestion
Salivary insulin concentration
Changes in salivary insulin concentration from saliva
Measured: Baseline, 15, 25, and 32 minutes post-ingestion
Prefrontal Cortex Oxygenation
Near-infrared spectroscopy
Measured: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Peripheral Vascular Conductance
Blood flow in the brachial artery normalized to blood pressure (mL/min/mmHg)
Measured: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Electromyography
Electromyographic reading of muscle activity of the active muscles (glutes, hamstrings, quadriceps, and calves)
Measured: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion
Peripheral Blood Flow
Doppler ultrasound derived blood flow in the brachial artery
Measured: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue; Muscle, HeartStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Austin Graybeal, University of Southern Mississippi
- Investigators
- Austin J Graybeal, PhD, Principal investigator, University of Southern Mississippi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529055
- Sponsor's protocol ID
- 24-0285
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 2 Aug 2024
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
- ClinicalTrials.gov ID
- NCT06529055
- Acronym / sponsor ID
- 24-0285
- Conditions
- Fatigue; Muscle, Heart, Fatigue, Mental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Jul 2024 (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 goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40.
Accordingly, the primary aims of the study are to determine the effects of acute oral nicotine pouches, oral caffeine pouches, or both, on measures of
- anaerobic performance
- cognition
- cardiovascular and autonomic function
- appetite and food intake.
Researchers will compare oral nicotine pouches, oral caffeine pouches, both oral nicotine and caffeine pouches, and a flavor and color matched placebo to see if how they differentially affect measurements of
- physical performance,
- cognition,
- cardiovascular and autonomic function
- appetite and food intake.
On four separate occasions, participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling, cognitive, and balance tests while blood and salivary biomarkers, subjective appetite ratings, and cardiovascular and autonomic function measurements are collected. After each trial, participants will complete a 24-hr food record.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Nicotine Pouches | Experimental | Other: Oral Pouch - NicotineSingle dose 3mg oral nicotine pouch |
| Oral Caffeine Pouches | Experimental | Other: Oral Pouch - CaffeineSingle dose 100mg oral caffeine pouch |
| Combination of oral nicotine and caffeine pouches | Experimental | Other: Oral Pouch - Nicotine, Other: Oral Pouch - CaffeineSingle simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch |
| Placebo | Placebo comparator | Other: Oral Pouch - PlaceboFlavor, color, and appearance matched placebo |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being 21 to 40 years of age
- Being biologically male
- Having a body mass index (BMI) of < 30 kilograms/meter-squared
- Participating in moderate/vigorous exercise for at least 150 minutes/week over the last month
Key exclusion criteria (17 listed)
- individuals who are younger than 21 or older than 40
- missing any limbs or part of a limb
- having any neuromuscular/musculoskeletal injury or impairment that would prevent performing any exercise/functional measures for this study
- having a pacemaker or any other electrical implant
- a diagnosis (defined as the presence of disease of or using medication to treat the disease) of heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease, type I or type II diabetes
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 |
|---|---|---|
| Oral Pouch - NicotineIngestion of a randomized oral nicotine pouch | Other | Combination of oral nicotine and caffeine pouches, Oral Nicotine Pouches |
| Oral Pouch - CaffeineIngestion of a randomized oral caffeine pouch | Other | Combination of oral nicotine and caffeine pouches, Oral Caffeine Pouches |
| Oral Pouch - PlaceboIngestion of a randomized oral placebo pouch | Other | Placebo |
Primary outcome
Wingate Anaerobic Cycling Test
Time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Changes in anaerobic cycling power output
Concentration of blood lactate
Time frame: Baseline, 25, 32 minutes post-ingestion
Changes in blood lactate concentration from capillary blood
Concentration of salivary cortisol
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in salivary cortisol concentration from saliva
Concentration of salivary interleukin-6
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in interleukin-6 concentration from saliva
Salivary catecholamine concentration
Time frame: Baseline, 15, 27, 40 minutes post-ingestion
Changes in salivary catecholamine concentration from saliva
Profile of Mood States
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in Profile of Mood States scores (Score range: 0-60)
Balance
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in standing postural sway
Ratings of perceived exertion
Time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Changes in ratings of perceived exertion (Scale range: 6-20 - lower ratings means less effort))
Hunger - Visual Digital Analog Scale (0-100)
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Changes in subjective ratings of hunger
Desire to eat - Visual Digital Analog Scale (0-100)
Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of desire to eat
Prospective Consumption of Food - Visual Digital Analog Scale (0-100)
Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of prospective consumption of food
Fullness - Visual Digital Analog Scale (0-100)
Time frame: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of fullness
Food Intake - Digital 24-hour food record
Time frame: 24 hours following the end of each visit
Consumption of food and beverage after study visit
Blood Pressure
Time frame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Absolute brachial blood pressure values (systolic and diastolic) and relative changes from baseline.
Heart Rate
Time frame: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Absolute heart rate values and relative changes from baseline.
Trail Making Test - Digital Cognitive Function Test
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in trail making test scores
Sustained Attention Test - Digital Cognitive Function Test
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in sustained attention test scores
Visual Working Memory Span Test - Digital Cognitive Function Test
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in visual working memory span test scores
Stroop Test - Digital Cognitive Function Test
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in Stroop test scores
Deary-Liewald Test - Digital Cognitive Function Test
Time frame: Baseline, 15, 32 minutes post-ingestion
Changes in Deary-Liewald test scores
Cerebral Blood flow
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Doppler ultrasound derived blood flow in the carotid artery
6 secondary outcomes
Blood Glucose Concentration
Time frame: Baseline, 15, 25, 32 minutes post-ingestion
Salivary insulin concentration
Time frame: Baseline, 15, 25, and 32 minutes post-ingestion
Prefrontal Cortex Oxygenation
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Peripheral Vascular Conductance
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Electromyography
Time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion
Peripheral Blood Flow
Time frame: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- 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.
Austin J Graybeal, PhD principal investigator
University of Southern Mississippi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Pouch - Nicotine and Oral Pouch - Caffeine in people with Fatigue; Muscle, Heart and Fatigue, Mental, run by University of Southern Mississippi 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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. 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?
Results are not available in the source record.
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?
Wingate Anaerobic Cycling Test (time frame: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion). The study lists 21 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 2 Aug 2024.