Neutrophil Chemotactic ResponseNCT02411318
Influence of Lifestyle Factors on Neutrophil Migration Pilot Study
A study testing Exercise, ProLab 200mg caffeine capsule and Ethanol ingestion in people with Neutrophil Chemotactic Response, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will determine how common lifestyle practices affect the behavior of neutrophils (a type of immune cell) at shorter time scales than previously possible. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neutrophil Chemotactic Response
- What is being tested?
- Exercise, ProLab 200mg caffeine capsule and Ethanol ingestion
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2014to 31 Dec 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capacity to provide informed consent and ability to speak and read English.
- Male or female with no chronic or acute health concerns that might affect subject safety during the study or interfere with the study results
- No intake of medication that the researchers believe will significantly influence immune function in the 48 hours proceeding the lancet puncture (examples given in the section entitled "Exclusion Criteria")
- In good physical health
- Regularly exercise at least 30 minutes 3 times per week (exercise cohort)
Who cannot join
- Currently participating in another clinical trial
- History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease)
- Use of beta blockers or corticosteroids
- Currently taking medications that are not recommended to be taken in conjunction with alcohol
- Acute illness or evidence of clinically significant active infection
- Currently receiving immunotherapy
Show all 13Show fewer
- Pregnant women
- Ingested medication (e.g. systemic corticosteroids) within 48 hours preceding the draw that the researchers believe may have an effect on immune response or the immune system
- Performed any activity that conflicts (eg. drinking any alcohol prior to the study), in the judgment of the investigator, with the external factor to be tested in the study (if any)
- Alcoholic or other health conditions for which alcohol consumption is contraindicated
- Consume more than 7 drinks per week (women alcohol cohort)
- Consume more than 14 drinks per week (men alcohol cohort)
- Consume more than three (8 oz.) servings of coffee, caffeinated soft drinks/tea (12 oz.) per day (caffeine cohort)
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine how common lifestyle practices affect the behavior of neutrophils (a type of immune cell) at shorter time scales than previously possible.
Read the detailed description
This study will investigate how external factors implicated in immunity such as exercise, caffeine ingestion, ethanol, glucose, and glucose and caffeine ingestion influence neutrophil migration.
Neutrophils are the most prominent immune cell in human blood and are involved in a complex equilibrium of immune protection and autoimmune damage. Their recruitment to an inflammatory or wounding site is controlled by the sensing and directed migration to a concentration gradient of attractant molecules, a process called chemotaxis. Immune cells are also implicated in many diseases including cancer. The ability to measure the amplitude of a response over time for a specific patient, and the variation of this response when the patient engages in certain activities or consumes certain substances will improve understanding of how certain lifestyle factors impact the immune response. Traditional assays require large volumes of blood and a long purification process, which may affect neutrophil function and strictly limits the number of draws possible from a single patient. The novel microfluidic assay proposed limits these drawbacks as it has the capability to purify neutrophils from a 3 µL drop of blood in less than 5 minutes and measure their chemotaxis in a gradient of chemokines. Critically, the proposed studies will begin to fill a gap in current understanding of immune response as previous studies focused on single endpoints likely missing early events in the response to external stimulus. Understanding this temporal response may have implications in the development of new treatments as well as improvements in diagnosis of improper immune response.
The KOALA (Kit On A Lid Assay) approach was developed in Professor Dave Beebe's lab and has been validated in a mouse model and in human asthmatic patients. In a collaboration with Dr. Anna Huttenlocher, it has been shown that, in contrast to traditional neutrophil purification, KOALA can be performed with small volumes of blood, and a much quicker purification time.
Due to its unique qualities, KOALA allows for repeated evaluation of neutrophil adhesion and chemotaxis properties, thus making it an attractive method for studying dynamic neutrophil changes that may occur as a result of an external factor.
Using traditional macrobiology tools, researchers have identified several factors that may play important roles in reducing neutrophil responsiveness and migration ability. Lifestyle and diet factors, amongst others, have been shown to impact neutrophil count, migration and biochemical function. For example, sleep deprivation has been linked with higher neutrophil count, despite a known immuno-depressive effect. Physical exercise results in increased neutrophil counts and increased neutrophil degranulation. Dietary factors, such as caffeine and ethanol have been shown to impact immune function.
Blood glucose will be tested at each time point using a blood glucose monitor to determine whether the lifestyle factor is affecting blood glucose (and consequently, neutrophil function). Alcohol consumption can cause both high and low blood sugar. Specifically, while low doses of alcohol may have a protective effect against risk of diabetes and metabolic syndrome, heavy drinking has been associated with higher glucose levels, resulting in increased risk of both diabetes and metabolic syndrome. Similarly, acute ingestion of caffeine has been shown to increase blood glucose levels, but several epidemiological studies have shown regular coffee consumption in associated with a lower risk of type 2 diabetes. Measuring blood glucose on subjects in the glucose study may show dose dependent effects on neutrophils.
To build on this research, the investigators intend to probe the role of these lifestyle factors on neutrophil migration over much shorter time scales than has been previously studied. The investigators propose to examine the effects of exercise, ethanol ingestion and caffeine consumption on neutrophil behavior.
Whole blood obtained from subjects by finger stick will be used in KOALA to isolate neutrophils. Neutrophil function will be assessed by measuring absolute migration speed, chemotactic index and chemotaxis velocity (directional velocity toward the formation of the gradient of chemoattractant).
The primary outcome of this study will be to determine whether exercise, caffeine consumption, ethanol, glucose and combined glucose and caffeine ingestion affect neutrophil chemotactic velocity. The secondary outcomes are to determine whether exercise, caffeine consumption, ethanol, glucose and combined glucose and caffeine ingestion affect the absolute speed and chemotactic index of neutrophils. The investigators will also assess whether cytokine profiles in the blood change as a result of engaging int he specified lifestyle factors.
- Conditions
- Neutrophil Chemotactic Response
- Being tested
- Exercise, ProLab 200mg caffeine capsule, Ethanol ingestion, Glucose Tolerance Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will ride a stationary bike and maintain their target heart rate (according to the American Heart Association guidelines) for 30 minutes.
ProLab 200mg caffeine capsuleDrug
Participants will swallow one ProLab caffeine 200mg tablet.
Ethanol ingestionOther
Participants will consume a dose of 80 proof alcohol according to their body weight to reach a breath alcohol concentration of 0.05.
Glucose Tolerance DrinkDrug
Participants will consume 100 grams of glucose
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Exercise | Experimental | Participants will ride a stationary bike and maintain their target heart rate (according to the American Heart Association guidelines) for 30 minutes. For example, a 30 year old will have a target heart rate zone of 95-162 beats per minute. A baseline blood sample will be acquired before the participant begins exercising. In the following 30 minutes, participants will ride the exercise bike, and their heart rate and general status will be assessed continuously. Specifically, heart rate will be monitored using a chest strap heart rate monitor. Two additional lancet punctures will be performed after the exercise to measure the changes in neutrophil function: one immediately following the 30 minute exercise period and one 30 minutes after the exercise has been completed. Receives: Behavioral: Exercise |
| Caffeine Consumption | Experimental | Participants will be exposed to a moderate dose of caffeine (200 mg capsule in one sitting) from a common commercial product. After consent and screening, a baseline blood sample will be acquired using the lancet puncture procedure. The participant will then be instructed to swallow a 200 mg caffeine capsule. Two additional lancet punctures will be performed after the caffeine ingestion: one after 30 minutes post-ingestion and another one after 60 minutes. Receives: Drug: ProLab 200mg caffeine capsule |
| Ethanol Ingestion | Experimental | Participants will be weighed and their required alcohol dose determined according to the equation used by the Madison Police Department during alcohol training workshops: 1 mL of 80 proof (40%) alcohol per pound of body weight. Participants will be permitted to consume the drink at their own pace, although no slower than one drink per hour. Breath Alcohol Concentration (BAC) will be tested 20 minutes after drinking has ceased in order to clear mouth alcohol that may affect the BAC reading. Participants at 0.05 BAC and above will have blood drawn via lancet puncture. In addition to the lancet puncture done once the alcohol level is reached, an additional lancet puncture will be performed 1 hour later. Receives: Other: Ethanol ingestion |
| Glucose Ingestion | Experimental | After a baseline blood sample is acquired, participants will consume 100 grams of glucose within 5 minutes. Two additional lancet punctures will be performed after the glucose ingestion, one at 30 minutes post-ingestion, and one at 60 minutes post-ingestion. Receives: Drug: Glucose Tolerance Drink |
| Glucose and Caffeine Ingestion | Experimental | After a baseline blood sample is acquired, participants will swallow 200mg of caffeine in capsule form and consume 100 grams of glucose within 5 minutes. Two additional lancet punctures will be performed after the caffeine and glucose ingestion, one at 30 minutes post-ingestion, and one at 60 minutes post-ingestion. Receives: Drug: ProLab 200mg caffeine capsule; Drug: Glucose Tolerance Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise-Related Neutrophil Chemotactic Velocity
Participants will ride a stationary bike and maintain their target heart rate for 30 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Caffeine-Related Neutrophil Chemotactic Velocity
Participants will consume a moderate dose of caffeine via 200mg capsule. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Ethanol-Related Neutrophil Chemotactic Velocity
Participants will consume a weight-calculated dose of alcohol sufficient to increase their blood alcohol concentration (BAC) to 0.05. Blood samples via lancet will be collected at baseline, 1-3 hours (when BAC reached 0.05) and 1 hour after previous collection.
Measured: baseline, 1-3 hours from baseline, up to 2-4 hours from baseline
Change in Glucose-Related Neutrophil Chemotactic Velocity
Participants will consume 100g glucose tolerance drink within 5 minutes. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Caffeine Plus Glucose-Related Neutrophil Chemotactic Velocity
Participants will consume a moderate dose of caffeine via 200mg capsule and 100g of glucose tolerance drink within 5 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Secondary outcomes (10)
Change in Exercise-Related Neutrophil Absolute Speed
Participants will ride a stationary bike and maintain their target heart rate for 30 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Exercise-Related Neutrophil Chemotactic Index
Participants will ride a stationary bike and maintain their target heart rate for 30 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Caffeine-Related Neutrophil Absolute Speed
Participants will consume a moderate dose of caffeine via 200mg capsule. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Caffeine-Related Neutrophil Chemotactic Index
Participants will consume a moderate dose of caffeine via 200mg capsule. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Ethanol-Related Neutrophil Absolute Speed
Participants will consume a weight-calculated dose of alcohol sufficient to increase their blood alcohol concentration (BAC) to 0.05. Blood samples via lancet will be collected at baseline, 1-3 hours (when BAC reached 0.05) and 1 hour after previous collection.
Measured: baseline, 1-3 hours from baseline, up to 2-4 hours from baseline
Change in Ethanol-Related Neutrophil Chemotactic Index
Participants will consume a weight-calculated dose of alcohol sufficient to increase their blood alcohol concentration (BAC) to 0.05. Blood samples via lancet will be collected at baseline, 1-3 hours (when BAC reached 0.05) and 1 hour after previous collection.
Measured: baseline, 1-3 hours from baseline, up to 2-4 hours from baseline
Change in Glucose-Related Neutrophil Absolute Speed
Participants will consume 100g glucose tolerance drink within 5 minutes. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Glucose-Related Neutrophil Chemotactic Index
Participants will consume 100g glucose tolerance drink within 5 minutes. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Caffeine Plus Glucose-Related Neutrophil Absolute Speed
Participants will consume a moderate dose of caffeine via 200mg capsule and 100g of glucose tolerance drink within 5 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Change in Caffeine Plus Glucose-Related Neutrophil Chemotactic Index
Participants will consume a moderate dose of caffeine via 200mg capsule and 100g of glucose tolerance drink within 5 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Measured: baseline, 30 min, 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start25 Sep 2014
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neutrophil Chemotactic ResponseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Beebe, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411318
- Sponsor's protocol ID
- 2014-0218
- Other IDs
- A194200, ENGR\BIOMEDICAL ENGR
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2015
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bagby GJ, Zhang P, Stoltz DA, Nelson S. Suppression of the granulocyte colony-stimulating factor response to Escherichia coli challenge by alcohol intoxication. Alcohol Clin Exp Res. 1998 Nov;22(8):1740-5.
PubMed 9835289Bird MD, Zahs A, Deburghgraeve C, Ramirez L, Choudhry MA, Kovacs EJ. Decreased pulmonary inflammation following ethanol and burn injury in mice deficient in TLR4 but not TLR2 signaling. Alcohol Clin Exp Res. 2010 Oct;34(10):1733-41. doi: 10.1111/j.1530-0277.2010.01260.x. Epub 2010 Jul 1.
PubMed 20608903Boe DM, Nelson S, Zhang P, Quinton L, Bagby GJ. Alcohol-induced suppression of lung chemokine production and the host defense response to Streptococcus pneumoniae. Alcohol Clin Exp Res. 2003 Nov;27(11):1838-45. doi: 10.1097/01.ALC.0000095634.82310.53.
PubMed 14634502Boudjeltia KZ, Faraut B, Stenuit P, Esposito MJ, Dyzma M, Brohee D, Ducobu J, Vanhaeverbeek M, Kerkhofs M. Sleep restriction increases white blood cells, mainly neutrophil count, in young healthy men: a pilot study. Vasc Health Risk Manag. 2008;4(6):1467-70. doi: 10.2147/vhrm.s3934.
PubMed 19337560Chimenti L, Morici G, Paterno A, Santagata R, Bonanno A, Profita M, Riccobono L, Bellia V, Bonsignore MR. Bronchial epithelial damage after a half-marathon in nonasthmatic amateur runners. Am J Physiol Lung Cell Mol Physiol. 2010 Jun;298(6):L857-62. doi: 10.1152/ajplung.00053.2010. Epub 2010 Apr 2.
PubMed 20363849Horrigan LA, Kelly JP, Connor TJ. Caffeine suppresses TNF-alpha production via activation of the cyclic AMP/protein kinase A pathway. Int Immunopharmacol. 2004 Oct;4(10-11):1409-17. doi: 10.1016/j.intimp.2004.06.005.
PubMed 15313438Sackmann EK, Berthier E, Young EW, Shelef MA, Wernimont SA, Huttenlocher A, Beebe DJ. Microfluidic kit-on-a-lid: a versatile platform for neutrophil chemotaxis assays. Blood. 2012 Oct 4;120(14):e45-53. doi: 10.1182/blood-2012-03-416453. Epub 2012 Aug 22.
PubMed 22915642Sackmann EK, Berthier E, Schwantes EA, Fichtinger PS, Evans MD, Dziadzio LL, Huttenlocher A, Mathur SK, Beebe DJ. Characterizing asthma from a drop of blood using neutrophil chemotaxis. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5813-8. doi: 10.1073/pnas.1324043111. Epub 2014 Apr 7.
PubMed 24711384
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lifestyle Factors on Neutrophil Migration Pilot Study
- ClinicalTrials.gov ID
- NCT02411318
- Acronym / sponsor ID
- 2014-0218
- Conditions
- Neutrophil Chemotactic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 25 Sep 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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.
This study will determine how common lifestyle practices affect the behavior of neutrophils (a type of immune cell) at shorter time scales than previously possible.
Detailed description
This study will investigate how external factors implicated in immunity such as exercise, caffeine ingestion, ethanol, glucose, and glucose and caffeine ingestion influence neutrophil migration.
Neutrophils are the most prominent immune cell in human blood and are involved in a complex equilibrium of immune protection and autoimmune damage. Their recruitment to an inflammatory or wounding site is controlled by the sensing and directed migration to a concentration gradient of attractant molecules, a process called chemotaxis. Immune cells are also implicated in many diseases including cancer. The ability to measure the amplitude of a response over time for a specific patient, and the variation of this response when the patient engages in certain activities or consumes certain substances will improve understanding of how certain lifestyle factors impact the immune response. Traditional assays require large volumes of blood and a long purification process, which may affect neutrophil function and strictly limits the number of draws possible from a single patient. The novel microfluidic assay proposed limits these drawbacks as it has the capability to purify neutrophils from a 3 µL drop of blood in less than 5 minutes and measure their chemotaxis in a gradient of chemokines. Critically, the proposed studies will begin to fill a gap in current understanding of immune response as previous studies focused on single endpoints likely missing early events in the response to external stimulus. Understanding this temporal response may have implications in the development of new treatments as well as improvements in diagnosis of improper immune response.
The KOALA (Kit On A Lid Assay) approach was developed in Professor Dave Beebe's lab and has been validated in a mouse model and in human asthmatic patients. In a collaboration with Dr. Anna Huttenlocher, it has been shown that, in contrast to traditional neutrophil purification, KOALA can be performed with small volumes of blood, and a much quicker purification time.
Due to its unique qualities, KOALA allows for repeated evaluation of neutrophil adhesion and chemotaxis properties, thus making it an attractive method for studying dynamic neutrophil changes that may occur as a result of an external factor.
Using traditional macrobiology tools, researchers have identified several factors that may play important roles in reducing neutrophil responsiveness and migration ability. Lifestyle and diet factors, amongst others, have been shown to impact neutrophil count, migration and biochemical function. For example, sleep deprivation has been linked with higher neutrophil count, despite a known immuno-depressive effect. Physical exercise results in increased neutrophil counts and increased neutrophil degranulation. Dietary factors, such as caffeine and ethanol have been shown to impact immune function.
Blood glucose will be tested at each time point using a blood glucose monitor to determine whether the lifestyle factor is affecting blood glucose (and consequently, neutrophil function). Alcohol consumption can cause both high and low blood sugar. Specifically, while low doses of alcohol may have a protective effect against risk of diabetes and metabolic syndrome, heavy drinking has been associated with higher glucose levels, resulting in increased risk of both diabetes and metabolic syndrome. Similarly, acute ingestion of caffeine has been shown to increase blood glucose levels, but several epidemiological studies have shown regular coffee consumption in associated with a lower risk of type 2 diabetes. Measuring blood glucose on subjects in the glucose study may show dose dependent effects on neutrophils.
To build on this research, the investigators intend to probe the role of these lifestyle factors on neutrophil migration over much shorter time scales than has been previously studied. The investigators propose to examine the effects of exercise, ethanol ingestion and caffeine consumption on neutrophil behavior.
Whole blood obtained from subjects by finger stick will be used in KOALA to isolate neutrophils. Neutrophil function will be assessed by measuring absolute migration speed, chemotactic index and chemotaxis velocity (directional velocity toward the formation of the gradient of chemoattractant).
The primary outcome of this study will be to determine whether exercise, caffeine consumption, ethanol, glucose and combined glucose and caffeine ingestion affect neutrophil chemotactic velocity. The secondary outcomes are to determine whether exercise, caffeine consumption, ethanol, glucose and combined glucose and caffeine ingestion affect the absolute speed and chemotactic index of neutrophils. The investigators will also assess whether cytokine profiles in the blood change as a result of engaging int he specified lifestyle factors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Exercise | Experimental | Behavioral: ExerciseParticipants will ride a stationary bike and maintain their target heart rate (according to the American Heart Association guidelines) for 30 minutes. For example, a 30 year old will have a target heart rate zone of 95-162 beats per minute. A baseline blood sample will be acquired before the participant begins exercising. In the following 30 minutes, participants will ride the exercise bike, and their heart rate and general status will be assessed continuously. Specifically, heart rate will be monitored using a chest strap heart rate monitor. Two additional lancet punctures will be performed after the exercise to measure the changes in neutrophil function: one immediately following the 30 minute exercise period and one 30 minutes after the exercise has been completed. |
| Caffeine Consumption | Experimental | Drug: ProLab 200mg caffeine capsuleParticipants will be exposed to a moderate dose of caffeine (200 mg capsule in one sitting) from a common commercial product. After consent and screening, a baseline blood sample will be acquired using the lancet puncture procedure. The participant will then be instructed to swallow a 200 mg caffeine capsule. Two additional lancet punctures will be performed after the caffeine ingestion: one after 30 minutes post-ingestion and another one after 60 minutes. |
| Ethanol Ingestion | Experimental | Other: Ethanol ingestionParticipants will be weighed and their required alcohol dose determined according to the equation used by the Madison Police Department during alcohol training workshops: 1 mL of 80 proof (40%) alcohol per pound of body weight. Participants will be permitted to consume the drink at their own pace, although no slower than one drink per hour. Breath Alcohol Concentration (BAC) will be tested 20 minutes after drinking has ceased in order to clear mouth alcohol that may affect the BAC reading. Participants at 0.05 BAC and above will have blood drawn via lancet puncture. In addition to the lancet puncture done once the alcohol level is reached, an additional lancet puncture will be performed 1 hour later. |
| Glucose Ingestion | Experimental | Drug: Glucose Tolerance DrinkAfter a baseline blood sample is acquired, participants will consume 100 grams of glucose within 5 minutes. Two additional lancet punctures will be performed after the glucose ingestion, one at 30 minutes post-ingestion, and one at 60 minutes post-ingestion. |
| Glucose and Caffeine Ingestion | Experimental | Drug: ProLab 200mg caffeine capsule, Drug: Glucose Tolerance DrinkAfter a baseline blood sample is acquired, participants will swallow 200mg of caffeine in capsule form and consume 100 grams of glucose within 5 minutes. Two additional lancet punctures will be performed after the caffeine and glucose ingestion, one at 30 minutes post-ingestion, and one at 60 minutes post-ingestion. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Capacity to provide informed consent and ability to speak and read English.
- Male or female with no chronic or acute health concerns that might affect subject safety during the study or interfere with the study results
- No intake of medication that the researchers believe will significantly influence immune function in the 48 hours proceeding the lancet puncture (examples given in the section entitled "Exclusion Criteria")
- In good physical health
- Regularly exercise at least 30 minutes 3 times per week (exercise cohort)
Key exclusion criteria (13 listed)
- Currently participating in another clinical trial
- History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease)
- Use of beta blockers or corticosteroids
- Currently taking medications that are not recommended to be taken in conjunction with alcohol
- Acute illness or evidence of clinically significant active infection
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 |
|---|---|---|
| ExerciseParticipants will ride a stationary bike and maintain their target heart rate (according to the American Heart Association guidelines) for 30 minutes. | Behavioural | Cardiovascular Exercise |
| ProLab 200mg caffeine capsuleParticipants will swallow one ProLab caffeine 200mg tablet. | Drug | Caffeine Consumption, Glucose and Caffeine Ingestion |
| Ethanol ingestionParticipants will consume a dose of 80 proof alcohol according to their body weight to reach a breath alcohol concentration of 0.05. | Other | Ethanol Ingestion |
| Glucose Tolerance DrinkParticipants will consume 100 grams of glucose | Drug | Glucose Ingestion, Glucose and Caffeine Ingestion |
Primary outcome
Change in Exercise-Related Neutrophil Chemotactic Velocity
Time frame: baseline, 30 min, 60 min
Participants will ride a stationary bike and maintain their target heart rate for 30 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Change in Caffeine-Related Neutrophil Chemotactic Velocity
Time frame: baseline, 30 min, 60 min
Participants will consume a moderate dose of caffeine via 200mg capsule. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Change in Ethanol-Related Neutrophil Chemotactic Velocity
Time frame: baseline, 1-3 hours from baseline, up to 2-4 hours from baseline
Participants will consume a weight-calculated dose of alcohol sufficient to increase their blood alcohol concentration (BAC) to 0.05. Blood samples via lancet will be collected at baseline, 1-3 hours (when BAC reached 0.05) and 1 hour after previous collection.
Change in Glucose-Related Neutrophil Chemotactic Velocity
Time frame: baseline, 30 min, 60 min
Participants will consume 100g glucose tolerance drink within 5 minutes. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
Change in Caffeine Plus Glucose-Related Neutrophil Chemotactic Velocity
Time frame: baseline, 30 min, 60 min
Participants will consume a moderate dose of caffeine via 200mg capsule and 100g of glucose tolerance drink within 5 min. Blood samples via lancet will be collected at baseline, 30 min (immediately post intervention), and 60 min.
10 secondary outcomes
Change in Exercise-Related Neutrophil Absolute Speed
Time frame: baseline, 30 min, 60 min
Change in Exercise-Related Neutrophil Chemotactic Index
Time frame: baseline, 30 min, 60 min
Change in Caffeine-Related Neutrophil Absolute Speed
Time frame: baseline, 30 min, 60 min
Change in Caffeine-Related Neutrophil Chemotactic Index
Time frame: baseline, 30 min, 60 min
Change in Ethanol-Related Neutrophil Absolute Speed
Time frame: baseline, 1-3 hours from baseline, up to 2-4 hours from baseline
Change in Ethanol-Related Neutrophil Chemotactic Index
Time frame: baseline, 1-3 hours from baseline, up to 2-4 hours from baseline
Change in Glucose-Related Neutrophil Absolute Speed
Time frame: baseline, 30 min, 60 min
Change in Glucose-Related Neutrophil Chemotactic Index
Time frame: baseline, 30 min, 60 min
Change in Caffeine Plus Glucose-Related Neutrophil Absolute Speed
Time frame: baseline, 30 min, 60 min
Change in Caffeine Plus Glucose-Related Neutrophil Chemotactic Index
Time frame: baseline, 30 min, 60 min
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 17 Dec 2020.
- Background: PubMed 9835289Bagby GJ, Zhang P, Stoltz DA, Nelson S. Suppression of the granulocyte colony-stimulating factor response to Escherichia coli challenge by alcohol intoxication. Alcohol Clin Exp Res. 1998 Nov;22(8):1740-5.
- Background: PubMed 20608903Bird MD, Zahs A, Deburghgraeve C, Ramirez L, Choudhry MA, Kovacs EJ. Decreased pulmonary inflammation following ethanol and burn injury in mice deficient in TLR4 but not TLR2 signaling. Alcohol Clin Exp Res. 2010 Oct;34(10):1733-41. doi: 10.1111/j.1530-0277.2010.01260.x. Epub 2010 Jul 1.
- Background: PubMed 14634502Boe DM, Nelson S, Zhang P, Quinton L, Bagby GJ. Alcohol-induced suppression of lung chemokine production and the host defense response to Streptococcus pneumoniae. Alcohol Clin Exp Res. 2003 Nov;27(11):1838-45. doi: 10.1097/01.ALC.0000095634.82310.53.
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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.
David J Beebe, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, ProLab 200mg caffeine capsule and Ethanol ingestion in people with Neutrophil Chemotactic Response, run by University of Wisconsin, Madison 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 5 inclusion and 13 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 17 Dec 2020. 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. 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?
Change in Exercise-Related Neutrophil Chemotactic Velocity (time frame: baseline, 30 min, 60 min). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411318, which also lists 8 linked publications.
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 17 Dec 2020.