Influence of Lifestyle Factors on Neutrophil Migration Pilot Study

NCT02411318 | Completed

• 3 other identifiers: 2014-0218A194200ENGR\BIOMEDICAL ENGR
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neutrophil Chemotactic Response

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  baseline, 30 min, 60 min

Secondary Outcomes (10)

• Change in Exercise-Related Neutrophil Absolute Speed

  baseline, 30 min, 60 min

• Change in Exercise-Related Neutrophil Chemotactic Index

  baseline, 30 min, 60 min

• Change in Caffeine-Related Neutrophil Absolute Speed

  baseline, 30 min, 60 min

• Change in Caffeine-Related Neutrophil Chemotactic Index

  baseline, 30 min, 60 min

• Change in Ethanol-Related Neutrophil Absolute Speed

  baseline, 1-3 hours from baseline, up to 2-4 hours from baseline

Study Arms (5)

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.

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.

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.

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.

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.

Drug: ProLab 200mg caffeine capsule; Drug: Glucose Tolerance Drink

Interventions

Exercise BEHAVIORAL

Participants will ride a stationary bike and maintain their target heart rate (according to the American Heart Association guidelines) for 30 minutes.

Cardiovascular Exercise

ProLab 200mg caffeine capsule DRUG

Participants will swallow one ProLab caffeine 200mg tablet.

Caffeine Consumption; Glucose and Caffeine Ingestion

Ethanol ingestion OTHER

Participants will consume a dose of 80 proof alcohol according to their body weight to reach a breath alcohol concentration of 0.05.

Ethanol Ingestion

Glucose Tolerance Drink DRUG

Participants will consume 100 grams of glucose

Glucose Ingestion; Glucose and Caffeine Ingestion

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• In good physical health
• Regularly exercise at least 30 minutes 3 times per week (exercise cohort)
• 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
• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (8)

• 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.

  PMID: 9835289 BACKGROUND

• Bird 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.

  PMID: 20608903 BACKGROUND

• Boe 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.

  PMID: 14634502 BACKGROUND

• Boudjeltia 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.

  PMID: 19337560 BACKGROUND

• Chimenti 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.

  PMID: 20363849 BACKGROUND

• Horrigan 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.

  PMID: 15313438 BACKGROUND

• Sackmann 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.

  PMID: 22915642 BACKGROUND

• Sackmann 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.

  PMID: 24711384 BACKGROUND

MeSH Terms

Interventions

Exercise; Caffeine

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David J Beebe, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 8, 2015
• Study Start: September 25, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-03

Locations

US (1)