150 Participants Needed

Caffeinated Beverages for Well-being

VP
AI
Overseen ByAlethios, Inc.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand physical and emotional responses to caffeinated beverages. Participants will consume a test caffeinated drink and their usual caffeinated drink, allowing researchers to compare responses. Ideal candidates are generally healthy adults who regularly consume caffeine and are willing to replace their usual drink with the test beverage. Participants should also be comfortable using their own wearable device and smartphone or computer to share data. As an unphased trial, this study provides an opportunity to contribute to a broader understanding of caffeine's effects on the body.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that caffeine is generally safe for most healthy adults. Studies have found that moderate caffeine consumption is usually well-tolerated. However, some individuals might experience negative effects, such as sleep problems, addiction, and heart issues like irregular heartbeats.

Excessive caffeine can be harmful. Energy drinks, often high in caffeine, have been linked to serious heart problems, including rare cases of sudden cardiac arrest.

Overall, healthy individuals who consume caffeine in moderation are likely safe. However, monitoring caffeine intake and paying attention to the body's signals is important.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of caffeinated beverages for well-being because it explores whether different types of caffeinated drinks can improve mental and physical health. While traditional caffeinated beverages like coffee and tea are popular for boosting energy, this trial tests a specific caffeinated beverage against participants' usual choices to see if it offers any unique benefits. The study could reveal whether the new beverage provides superior mood enhancement, increased alertness, or other well-being improvements compared to standard options.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of a test caffeinated beverage with participants' typical caffeinated beverage. Research has shown that caffeine can increase alertness, enhance mood, and improve cognitive clarity. Some studies suggest that regular caffeine consumption may boost physical activity and help reduce stress-related depression. However, the effects on mood can vary, with benefits often observed in regular caffeine consumers. It is also important to note that caffeine can sometimes cause anxiety and sleep disturbances. Overall, while caffeine may positively impact well-being, its effects can vary from person to person.26789

Who Is on the Research Team?

KN

Kristin Nieman, PhD

Principal Investigator

Nlumn LLC

Are You a Good Fit for This Trial?

Adults aged 18-55 with a BMI of 18.5-29.9, in good health, who regularly consume caffeine and are willing to switch to the test beverage. Must own a wearable device and have internet access for study compliance. Excludes pregnant women, those on certain medications or with specific medical conditions like high blood pressure, cancer, GI surgeries, substance abuse history, or significant weight changes recently.

Inclusion Criteria

I am willing to change my daily caffeine routine for the study's beverage.
Willing and able to comply with all study procedures
BMI ≥18.5 and <29.9 kg/m2
See 7 more

Exclusion Criteria

My prescription medication use is stable.
I use medications or supplements that contain caffeine or interact with it.
I have high blood pressure but am not taking medication for it.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume caffeinated beverages and are assessed for subjective and physiological responses

5 days
Daily consumption with remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Caffeinated Beverages

Trial Overview

The trial is testing how a new caffeinated beverage affects well-being compared to participants' usual caffeinated drinks. It measures subjective experiences and physiological responses using personal wearables and requires adherence to lifestyle guidelines during the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Test caffeinated beverage followed by participants' typical caffeinated beverageExperimental Treatment2 Interventions
Group II: Participants' typical caffeinated beverage followed by test caffeinated beverageExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.

Lead Sponsor

Nlumn LLC

Collaborator

Alethios, Inc.

Collaborator

Citations

Longitudinal Effects of Lifetime Caffeine Consumption on ...

On this basis, a study showed that regular-chronic caffeine consumption improved locomotor activity and reversed stress-induced depression and ...

The association of caffeine consumption with positive affect ...

Some studies have found mood improvements only in habitual caffeine consumers. However, the evidence is mixed with mood improvements also being ...

What doctors wish patients knew about the impact of caffeine

It can also have positive effects on alertness, cognitive function and athletic function. But as we indulge in our favorite caffeinated beverages, there are ...

A Review of Energy Drinks and Mental Health, with a Focus ...

At the multivariate level, however, low (0.1–133 mg/w) caffeine consumption from energy drinks was related to high stress levels, although no such observation ...

Energy Drinks and Mental Health

Yes. Energy drinks have been linked to anxiety, poor sleep, mood swings, and higher rates of risk-taking behavior. These factors are closely connected to ...

The Safety of Ingested Caffeine: A Comprehensive Review

We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful.

Why new wellness-branded energy drinks have health experts ...

Research has linked energy drinks to cardiovascular issues like arrhythmias and, in rare but potentially fatal cases, sudden cardiac arrest, ...

Coffee's Impact on Health and Well-Being - PMC

Drinking caffeinated coffee was associated with a 25% to 30% lower risk of fall in older adults in two cohort studies in Spain and in the UK [33].

Caffeine Consumption Patterns, Health Impacts, and Media ...

However, these benefits come with risks such as addiction, cardiovascular issues, and detrimental effects on sleep. Demographic data reveal ...