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Recruiting

NCT Number: NCT07357818

Effects of Caffeinated Beverages on Well-being

This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverages in generally healthy adults.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alethios, Inc.

San Francisco, California, 94109, United States

Location status: Recruiting

Location contact

Alethios, Inc.

CONTACT

[email protected]

650-206-8006

About this study

This will evaluate post-beverage subjective caffeine responses using visual analog scale questionnaires, mood, quality of life, and physiological responses to caffeine beverages compared to participants' habitual caffeine beverage intake in generally healthy adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females, ≥18 to ≤55 years of age
  • BMI ≥18.5 and <29.9 kg/m2
  • Generally good health
  • Participant currently and consistently has a caffeine routine
  • Participant is willing to substitute their current caffeine routine for the test beverage daily
  • Participant has never consumed the test beverage or similar products
  • Participant currently owns a wearable and is willing to use and connect the wearable device
  • Willing to use personal smart phone, tablet, or personal computer with stable internet connection
  • Willing and able to comply with all study procedures
  • Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study

Exclusion criteria

  • History or presence, on the basis of the health history, of clinically important condition or disease states
  • Is currently following, or planning to be on, a weight loss regimen
  • Weight loss or gain >4.5 kg
  • History of gastrointestinal surgery for weight reducing purposes or gastrointestinal (GI) conditions
  • History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
  • History of unconventional sleep patterns (e.g., night shift) or diagnosed sleep disorder
  • Use of tobacco/nicotine products
  • Use of hemp/marijuana products
  • Unstable use of any prescription medication
  • Use of any medications(s) or dietary supplement(s), containing caffeine, or interacting with caffeine
  • Recent history of alcohol or substance abuse
  • Exposed to any non-registered drug product
  • Self-report of hypertension/high blood pressure without use of hypertensive medications
  • Any known allergy or intolerance to any ingredients contained in the study product
  • Any signs or symptoms of active infection of clinical relevance
  • History or presence of cancer, except for non-melanoma skin cancer
  • History of any major trauma or major surgical event
  • Female who is pregnant, planning to be pregnant during the study period, lactating
  • An employee, close relative of an employee, or participant who has a financial interest in Sponsor company or any other caffeine beverage company.
  • Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol
  • A clinically significant medical condition that is affected by caffeine

Treatment and study plan

Participants' typical caffeinated beverage

Other

Participants will consume the caffeinated beverage they typically consume.

Test caffeinated beverage

Other

Participants will consume a test beverage that contains caffeine.

Primary outcomes

  1. Subjective caffeine visual analog scales

    Time frame: After 5 days of daily consumption

    Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.

Secondary outcomes

  1. Subjective caffeine visual analog scales

    Time frame: Up to 5 hours after beverage consumption

    Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.

  2. Subjective quality of life ratings

    Time frame: After 5 days of daily consumption

    Participants will rate how they feel using a Likert scale from 0-5. Where higher score indicate higher frequency in that feeling.

Other outcomes

  1. Physiological responses - Heart rate

    Time frame: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption

    Data collected by wearables

  2. Subjective beverage experience ratings

    Time frame: After 5 days of daily consumption

    Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.

  3. Physiological response - Sleep

    Time frame: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption

    Data collected by wearables

  4. Physiological responses - Activity

    Time frame: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption

    Data collected by wearables

Study contacts

Contact information is provided by the study sponsor or research team.

Alethios, Inc.

CONTACT

[email protected]

650-206-8006

VP Product Innovation, Guayaki Sustainable Rainforest Products

CONTACT

[email protected]

609-799-6067

Sponsors and collaborators

Lead sponsor

GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.

Industry

Collaborators

  • Alethios, Inc.
  • Nlumn LLC

Registry information

Official study title

A Randomized, Decentralized, Crossover, Open-Label Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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