Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease

Summary

Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are: * What is the feasibility of recruiting and retaining participants? * Are the study procedures appropriate to be translated to a larger future study? Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see if Participants will: * Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form. * Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours. * Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood.

Timeline

Start

2024-04-08

Primary completion

2024-08-10

Completion

2025-06-01

Publications

• Background Jett JD, Beck R, Tyutyunnyk D, Sanchez J, Lopez-Cruzan M, Ginsburg BC, McPherson SM, Javors MA, McDonell MG, Hill-Kapturczak N. Validation of the quantification of phosphatidylethanol 16:0/18:1 concentrations in TASSO-M20 devices. Alcohol Clin Exp Res (Hoboken). 2023 Apr;47(4):748-755. doi: 10.1111/acer.15024. Epub 2023 Feb 21.
• Background Shen X, Kellogg R, Panyard DJ, Bararpour N, Castillo KE, Lee-McMullen B, Delfarah A, Ubellacker J, Ahadi S, Rosenberg-Hasson Y, Ganz A, Contrepois K, Michael B, Simms I, Wang C, Hornburg D, Snyder MP. Multi-omics microsampling for the profiling of lifestyle-associated changes in health. Nat Biomed Eng. 2024 Jan;8(1):11-29. doi: 10.1038/s41551-022-00999-8. Epub 2023 Jan 19.
• Background Numao S, Uchida R, Kurosaki T, Nakagaichi M. Differences in circulating fatty acid-binding protein 4 concentration in the venous and capillary blood immediately after acute exercise. J Physiol Anthropol. 2021 Feb 10;40(1):5. doi: 10.1186/s40101-021-00255-z.
• Background Wik L, Nordberg N, Broberg J, Bjorkesten J, Assarsson E, Henriksson S, Grundberg I, Pettersson E, Westerberg C, Liljeroth E, Falck A, Lundberg M. Proximity Extension Assay in Combination with Next-Generation Sequencing for High-throughput Proteome-wide Analysis. Mol Cell Proteomics. 2021;20:100168. doi: 10.1016/j.mcpro.2021.100168. Epub 2021 Oct 27.
• Background Strimbu K, Tavel JA. What are biomarkers? Curr Opin HIV AIDS. 2010 Nov;5(6):463-6. doi: 10.1097/COH.0b013e32833ed177.
• Background O'Keefe JH, DiNicolantonio JJ, Lavie CJ. Coffee for Cardioprotection and Longevity. Prog Cardiovasc Dis. 2018 May-Jun;61(1):38-42. doi: 10.1016/j.pcad.2018.02.002. Epub 2018 Feb 21.
• Background Brown J, Kreiger N, Darlington GA, Sloan M. Misclassification of exposure: coffee as a surrogate for caffeine intake. Am J Epidemiol. 2001 Apr 15;153(8):815-20. doi: 10.1093/aje/153.8.815.
• Background Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.
• Background Lebeau PF, Byun JH, Platko K, Saliba P, Sguazzin M, MacDonald ME, Pare G, Steinberg GR, Janssen LJ, Igdoura SA, Tarnopolsky MA, Wayne Chen SR, Seidah NG, Magolan J, Austin RC. Caffeine blocks SREBP2-induced hepatic PCSK9 expression to enhance LDLR-mediated cholesterol clearance. Nat Commun. 2022 Feb 9;13(1):770. doi: 10.1038/s41467-022-28240-9.
• Background Temple JL, Bernard C, Lipshultz SE, Czachor JD, Westphal JA, Mestre MA. The Safety of Ingested Caffeine: A Comprehensive Review. Front Psychiatry. 2017 May 26;8:80. doi: 10.3389/fpsyt.2017.00080. eCollection 2017.
• Background Nawrot P, Jordan S, Eastwood J, Rotstein J, Hugenholtz A, Feeley M. Effects of caffeine on human health. Food Addit Contam. 2003 Jan;20(1):1-30. doi: 10.1080/0265203021000007840.
• Background Eshghi A, Pistawka AJ, Liu J, Chen M, Sinclair NJT, Hardie DB, Elliott M, Chen L, Newman R, Mohammed Y, Borchers CH. Concentration Determination of >200 Proteins in Dried Blood Spots for Biomarker Discovery and Validation. Mol Cell Proteomics. 2020 Mar;19(3):540-553. doi: 10.1074/mcp.TIR119.001820. Epub 2020 Jan 2.
• Background Bjorkesten J, Enroth S, Shen Q, Wik L, Hougaard DM, Cohen AS, Sorensen L, Giedraitis V, Ingelsson M, Larsson A, Kamali-Moghaddam M, Landegren U. Stability of Proteins in Dried Blood Spot Biobanks. Mol Cell Proteomics. 2017 Jul;16(7):1286-1296. doi: 10.1074/mcp.RA117.000015. Epub 2017 May 13.
• Background Fontaine E, Saez C. Capillary blood stability and analytical accuracy of 12 analytes stored in Microtainers(R). Pract Lab Med. 2023 Jul 5;36:e00325. doi: 10.1016/j.plabm.2023.e00325. eCollection 2023 Aug.
• Background Knitza J, Tascilar K, Vuillerme N, Eimer E, Matusewicz P, Corte G, Schuster L, Aubourg T, Bendzuck G, Korinth M, Elling-Audersch C, Kleyer A, Boeltz S, Hueber AJ, Kronke G, Schett G, Simon D. Accuracy and tolerability of self-sampling of capillary blood for analysis of inflammation and autoantibodies in rheumatoid arthritis patients-results from a randomized controlled trial. Arthritis Res Ther. 2022 May 25;24(1):125. doi: 10.1186/s13075-022-02809-7.
• Background Wickremsinhe E, Fantana A, Berthier E, Quist BA, Lopez de Castilla D, Fix C, Chan K, Shi J, Walker MG, Kherani JF, Knoderer H, Regev A, Harding JJ. Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of Abnormal Liver Chemistry. J Appl Lab Med. 2023 May 4;8(3):535-550. doi: 10.1093/jalm/jfac127.
• Background Khiali S, Agabalazadeh A, Sahrai H, Bannazadeh Baghi H, Rahbari Banaeian G, Entezari-Maleki T. Effect of Caffeine Consumption on Cardiovascular Disease: An Updated Review. Pharmaceut Med. 2023 Mar;37(2):139-151. doi: 10.1007/s40290-023-00466-y. Epub 2023 Mar 30.

Drugs

Indications

No indication recorded.