Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID07404254

A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine

Led by GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC. · Updated on 2026-02-11

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.

Lead Sponsor

N

Nlumn LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how different types of caffeinated beverages affect subjective feelings and physical responses in generally healthy adults who regularly consume caffeine. This randomized, double-blind trial focuses on adults aged 18 to 55 with a consistent caffeine routine to better understand mood, quality of life, and physical effects after drinking various caffeinated beverages. Participants will be assigned to one of three groups: a caffeinated low sugar beverage, a caffeinated beverage with standard sweetener and caffeine levels, or a control beverage with baseline sweetener and caffeine content. They will consume the assigned beverage daily for five days, with the study monitoring effects both shortly after consumption and over the five-day period. During the study, participants will complete visual analog scale questionnaires to report their caffeine-related feelings, mood, and quality of life. Physiological measures such as sleep patterns and physical activity will be tracked using wearable devices connected to personal smartphones or computers. The main outcome is subjective caffeine response measured on day five, with ongoing assessments up to five hours after each beverage intake. The total participation duration includes daily tracking and monitoring for five days.

CONDITIONS

Brief Title

Effects of Variations in Caffeinated Beverages on Well-being

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females aged 18 to 55 years
  • Body mass index (BMI) between 18.5 and less than 35.0 kg/m2
  • Generally good health
  • Currently has a consistent sweetened caffeine routine
  • Willing to replace current caffeine drinks with the test beverage daily
  • Never consumed the test beverage or similar products before
  • Owns a wearable device and willing to use it
  • Willing to use a smartphone, tablet, or computer with internet
  • Able and willing to comply with all study procedures
  • Willing to follow lifestyle considerations and sign informed consent
Not Eligible

You will not qualify if you...

  • History or presence of important medical conditions or diseases
  • Currently on or planning a weight loss regimen
  • Recent weight loss or gain over 4.5 kg
  • History of gastrointestinal surgery for weight loss or GI conditions
  • History of eating disorders such as anorexia, bulimia, or binge eating
  • Unusual sleep patterns or diagnosed sleep disorders
  • Use of tobacco or nicotine products
  • Use of hemp or marijuana products
  • Unstable use of prescription medications
  • Use of caffeine-containing medications or supplements
  • Recent alcohol or substance abuse
  • Exposure to unregistered drug products
  • Self-reported high blood pressure without medication
  • Allergies or intolerance to study product ingredients
  • Signs of active infection
  • History or presence of cancer except non-melanoma skin cancer
  • History of major trauma or surgery
  • Female who is pregnant, planning pregnancy, or breastfeeding
  • Employee or close relative of sponsor or caffeine beverage companies
  • Conditions that interfere with consent or study compliance
  • Medical condition affected by caffeine

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days

Participants consume assigned caffeinated beverages daily while subjective and physiological responses are monitored.

Daily consumption with assessments up to 5 hours after each beverage intake

Trial Site Locations

Total: 1 location

1

Alethios, Inc.

San Francisco, California, United States, 94109

Actively Recruiting

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Research Team

V

VP Product Innovation, Guayaki Sustainable Rainforest Products

A

Alethios, Inc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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