protocolSection identificationModule nctId: NCT06359197, orgStudyIdInfo id: 2024-17022-GRA, briefTitle: Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-08-10, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hamilton Health Sciences Corporation, class: OTHER, descriptionModule briefSummary: 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 ifParticipants 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., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: An external party will prepare an equal number of kits (n=18) containing all the required materials for the participants, both in the placebo and caffeine group. They will assign a unique random number to each of the packages; each number will correlate to either the placebo or caffeine group. When a participant agrees to the study, they will be given a unique participant ID number ranging from 0-36. Then, the external party will use a random number generator to pick the kit given to that participant. They will record the number associated with that kit, and link the kit number to the participant ID for tracking purposes. At the end of the study, the investigators will determine which participants received caffeine vs placebo based on the assigned random numbers., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Caffeine Pill, interventions name: Placebo, interventions name: TASSO+ Device, interventions name: Finger prick and collection on Whatman Protein 903 Saver Cards, interventions name: Intravenous Sampling, outcomesModule primaryOutcomes measure: Participant rate, primaryOutcomes measure: Participant Adherence, primaryOutcomes measure: Participant satisfaction, secondaryOutcomes measure: Significant changes in biomarkers observed after the ingestion of caffeine, secondaryOutcomes measure: Determine the correlation between capillary sampling and intravenous sampling, secondaryOutcomes measure: Determine the stability of capillary samples, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: David Braley Research Institute, city: Hamilton, state: Ontario, zip: L8L 2X2, country: Canada, contacts name: Luca Malatesta, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: caffeine@crlb-gmel.ca, contacts name: Megan Robertson, role: CONTACT, phone: 905-527-527-4322, phoneExt: 40311, email: caffeine@crlb-gmel.ca, contacts name: Guillaume Pare, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Hamilton General Hospital, city: Hamilton, state: Ontario, zip: L8L 2X2, country: Canada, contacts name: Luca Malatesta, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: caffeine@crlb-gmel.ca, contacts name: Megan Robertson, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: caffeine@crlb-gmel.ca, contacts name: Guillaume Pare, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: McMaster University, Department of Pathology and Molecular Medicine, city: Hamilton, state: Ontario, zip: L8S 4L8, country: Canada, contacts name: Luca Malatesta, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: caffeine@crlb-gmel.ca, contacts name: Megan Robertson, role: CONTACT, phone: 905-527-4322, phoneExt: 40311, email: caffeine@crlb-gmel.ca, contacts name: Guillaume Pare, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, hasResults: False