Feasibility Study for Investigating the Effect of Caffeine Consumption on Protein Biomarkers Related to Cardiovascular Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Participant Adherence
研究概览
简要总结
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.
详细描述
Proteomic biomarkers related to disease risk factors may shed light on the pathogenesis of different diseases. There is a knowledge gap in the effects of lifestyle interventions on the proteome, mainly because collection of blood samples by venipuncture for proteomics analysis is tedious and expensive. Discovering an at-home capillary blood collection method with samples that contain protein profiles that mirror or can be correlated to those of venous samples has the potential to greatly improve access to research studies. Cardiovascular diseases (CVD) are the most common cause of death worldwide. Caffeine is a commonly consumed substance. Many studies have shown a relationship between caffeine and reduced risk of CVD; however, the mechanisms remain mostly unknown.
The investigators are conducting a two-part feasibility study examining the effect of caffeine consumption on the relative levels of 92 cardiovascular-related protein biomarkers in samples obtained using different blood collection technologies to compare protein profiles between capillary and venous blood samples and further clarify the protective mechanisms of caffeine in mitigating CVD risk. By integrating both of these components into a single trial, the investigators aim to reduce the burden placed on participants, making the study easier and more accessible.
For the preliminary testing of the at-home blood collection methods compared with intravenous sampling, a group of 10 individuals (evenly split between male and female) will be recruited. In this phase, participants will be subject to blood collection by intravenous sampling, as well as the TASSO+ device and finger prick and collection on Whatman Protein 903 Saver Cards. After the first portion of the study is complete, data from the 10 patients will be analyzed to determine the most accurate and reliable capillary blood collection device. This sampling device will show a reasonable correlation to venipuncture, with a threshold of correlation above 70%.
For the larger at-home testing of the selected blood collection method, a group of 26 individuals will participate, again, with an even split between males and females. Participants in this second cohort will no longer have to come on premise for intravenous sampling. They can complete the entire study remotely, further reducing logistical challenges. In this phase, blood will only be collected using the capillary blood collection device that best correlates with venipuncture as validated in the first part of the study.
After the second portion of the study is complete, data from the first 10 participants will be integrated and compared with data from the second 26 participants to evaluate the effect of caffeine vs placebo on biomarkers, as well as identify any significant differences between the two cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be over the age of 18 to participate in the study. This is based on 400mg of caffeine being deemed safe for healthy adults.
排除标准
- •Participants are not to be pregnant or trying to get pregnant or lactating as the recommended caffeine consumption for these individuals is less than what would be administered in this study.
- •Individuals who are diabetic will be excluded from this study due to the fasting period, potentially leading to a low blood sugar state.
- •Individuals with the following conditions will be excluded from the study: Hypertension or a history of hypertension Glaucoma Thyroid disease Heart disease Seizure disorder The investigators will screen the participant's medical conditions and not include anyone whose condition may interfere.
- •Individuals who experience anxiety or have been diagnosed with other mental illnesses will want to consider their participation in this study. Those who experience anxiety may experience more anxiety-related symptoms with the consumption of caffeine. The investigators will screen participant's for anxiety-related disorders.
- •Individuals who have recently undergone major surgery. Major surgery is any intervention that has resulted in the penetration and opening of a body cavity (i.e., chest or abdominal). Recent is within the last month.
- •Individuals who are taking medication which may have adverse interactions with caffeine will be excluded from the study. The investigators will screen the participant's medications and not include anyone whose medications may interfere.
研究组 & 干预措施
Caffeine - Phase 1
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.
干预措施: Caffeine Pill (Drug)
Caffeine - Phase 1
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.
干预措施: TASSO+ Device (Device)
Caffeine - Phase 2
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.
干预措施: Caffeine Pill (Drug)
Caffeine - Phase 1
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.
干预措施: Finger prick and collection on Whatman Protein 903 Saver Cards (Device)
Caffeine - Phase 1
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.
干预措施: Intravenous Sampling (Device)
Control - Phase 1
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.
干预措施: Placebo (Drug)
Control - Phase 1
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.
干预措施: TASSO+ Device (Device)
Control - Phase 1
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.
干预措施: Finger prick and collection on Whatman Protein 903 Saver Cards (Device)
Control - Phase 1
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.
干预措施: Intravenous Sampling (Device)
Caffeine - Phase 2
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.
干预措施: TASSO+ Device (Device)
Control - Phase 2
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.
干预措施: Placebo (Drug)
Control - Phase 2
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.
干预措施: TASSO+ Device (Device)
结局指标
主要结局
Participant Adherence
时间窗: From enrollment to the end of intervention at 6 hours post caffeine or placebo consumption
To evaluate participant adherence, the investigators will determine the retention and follow-up rates as the participants move through the study. Their goal is to have an adherence rate of 95% as this will help to avoid attrition bias, which will ensure that there will be no significant differences between the analyzed cohort vs. participants who were lost to follow-up or withdrew from the study.
Participant rate
时间窗: From enrollment to the end of intervention at 6 hours post caffeine or placebo consumption
To evaluate participant rate, the investigators will determine (1) how many participants enter the study at a time, (2) how long it takes to recruit enough participants into the study, and (3) what are the refusal rates for participation. Their goal is to have a participant rate of 75%, meaning that they are able to recruit 75% of the people that are approached.
Participant satisfaction
时间窗: From enrollment to the end of intervention at 6 hours post caffeine or placebo consumption
User experience with the capillary blood collection devices will be evaluated using a satisfaction survey. Participants will rate their experience using a 5-point Likert scale ranging from extremely difficult (1 point) to extremely easy (5 points) for four questions related to ease-of-use, and from not usable (1 point) to no pain (5 points) for one question related to comfort of use. The investigators will consider a score of ≥20 to indicate acceptability and suitability of the device. They will consider achieving a satisfaction score of ≥20 from \>80% of participants to be feasible.
次要结局
- Determine the correlation between capillary sampling and intravenous sampling(From enrollment to the end of intervention at 6 hours post caffeine or placebo consumption in phase 1 cohort)
- Significant changes in biomarkers observed after the ingestion of caffeine(From enrollment to the end of intervention at 6 hours post caffeine or placebo consumption)
- Determine the stability of capillary samples(From enrollment to the end of intervention at 6 hours post caffeine or placebo consumption)