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Stimulant

Caffeine - Phase 2 for Healthy Subjects

Q: Is the inclusion criteria for this trial limited to individuals who have reached adulthood, specifically 18 years or older?

Individuals aged 18 to below 80 are eligible for enrollment in this research project.

Q: Which individuals meet the criteria to be considered for inclusion in this research study?

To be eligible for enrollment in this research study, potential participants must be individuals without known medical conditions and aged between 18 to 80 years. The trial aims to recruit approximately 36 subjects.

Q: Are eligible patients able to enroll in this ongoing trial at the present time?

As per the details on clinicaltrials.gov, this specific research investigation is presently not in need of additional participants. Although it was initially shared on 4/8/2024 and last revised on 4/5/2024, there are currently 1334 alternative studies actively seeking eligible candidates for participation.

Phase < 1

Waitlist Available

Led By Guillaume Pare, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of intervention at 6 hours post caffeine or placebo consumption

Awards & highlights

Study Summary

This trial is looking at how caffeine affects different biomarkers in the blood that may be related to cardiovascular disease. Researchers will give participants either a placebo or 400mg of caffeine in pill form and collect

Who is the study for?

This trial is for people with or without cardiovascular disease who are interested in how caffeine affects their body. Participants must be willing to fast overnight, take a caffeine pill or placebo, and have blood samples taken using different methods. They should not have conditions that exclude them from the study.Check my eligibility

What is being tested?

The trial tests the effects of a 400mg caffeine pill on blood biomarkers related to cardiovascular health versus a placebo. It also evaluates participant adherence and compares capillary blood sampling (using TASSO+ device and Whatman cards) with traditional venous sampling.See study design

What are the potential side effects?

Potential side effects may include those commonly associated with caffeine intake such as jitteriness, increased heart rate, upset stomach, restlessness, insomnia, and headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of intervention at 6 hours post caffeine or placebo consumption

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of intervention at 6 hours post caffeine or placebo consumption

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of intervention at 6 hours post caffeine or placebo consumption for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participant Adherence

Participant rate

Participant satisfaction

Secondary outcome measures

Determine the correlation between capillary sampling and intravenous sampling

Determine the stability of capillary samples

Significant changes in biomarkers observed after the ingestion of caffeine

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Caffeine - Phase 2Experimental Treatment2 Interventions

The sample size of this arm is 13 participants. In this arm, participants will remain at home to complete study procedures. They will undergo an overnight fast of at least 8 hours, then self-collect blood using the TASSO+ device. They will then ingest a 400mg dose of caffeine and remain fasted for the following 6 hours. At 3 hours and 6 hours post caffeine consumption, participants will collect their blood using the TASSO+ device.

Group II: Caffeine - Phase 1Experimental Treatment4 Interventions

The sample size of this arm is 5 participants. In this arm, participants will have to come to the Population Health Research Institute building to complete study procedures. They will undergo an overnight fast of at least 8 hours, then undergo blood collection by intravenous sampling, as well as by the TASSO+ device and finger prick and collection on Whatman Protein 903 Saver Cards. They will then ingest a 400mg dose of caffeine and remain fasted for the following 6 hours. At 3 hours and 6 hours post caffeine consumption, participants will have their blood collected in the same manner as the initial blood collection.

Group III: Control - Phase 1Placebo Group4 Interventions

The sample size of this arm is 5 participants. In this arm, participants will have to come to the Population Health Research Institute building to complete study procedures. They will undergo an overnight fast of at least 8 hours, then undergo blood collection by intravenous sampling, as well as by the TASSO+ device and finger prick and collection on Whatman Protein 903 Saver Cards. They will then ingest 2 placebo pills and remain fasted for the following 6 hours. At 3 hours and 6 hours post caffeine consumption, participants will have their blood collected in the same manner as the initial blood collection.

Group IV: Control - Phase 2Placebo Group2 Interventions

The sample size of this arm is 13 participants. In this arm, participants will remain at home to complete study procedures. They will undergo an overnight fast of at least 8 hours, then self-collect blood using the TASSO+ device. They will then ingest 2 placebo pills and remain fasted for the following 6 hours. At 3 hours and 6 hours post caffeine consumption, participants will collect their blood using the TASSO+ device.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,965 Total Patients Enrolled

Guillaume Pare, MDPrincipal InvestigatorPopulation Health Research Institute

2 Previous Clinical Trials

190 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this trial limited to individuals who have reached adulthood, specifically 18 years or older?

"Individuals aged 18 to below 80 are eligible for enrollment in this research project."

Answered by AI

Which individuals meet the criteria to be considered for inclusion in this research study?

"To be eligible for enrollment in this research study, potential participants must be individuals without known medical conditions and aged between 18 to 80 years. The trial aims to recruit approximately 36 subjects."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"As per the details on clinicaltrials.gov, this specific research investigation is presently not in need of additional participants. Although it was initially shared on 4/8/2024 and last revised on 4/5/2024, there are currently 1334 alternative studies actively seeking eligible candidates for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease

2024. "Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06359197.