Effects of Caffeinated Beverages on Well-being

NCT07357818 | Recruiting

• 1 other identifier: NL-2502
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caffeine; Healthy; Beverage Intake

Keywords

Caffeine beverages in health and well-being

Outcome Measures

Primary Outcomes (1)

• Subjective caffeine visual analog scales

  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.

  After 5 days of daily consumption

Secondary Outcomes (2)

• Subjective caffeine visual analog scales

  Up to 5 hours after beverage consumption

• Subjective quality of life ratings

  After 5 days of daily consumption

Other Outcomes (4)

• Physiological responses - Heart rate

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

• Subjective beverage experience ratings

  After 5 days of daily consumption

• Physiological response - Sleep

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

Study Arms (2)

Test caffeinated beverage followed by participants' typical caffeinated beverage

OTHER

Other: Participants' typical caffeinated beverage; Other: Test caffeinated beverage

Participants' typical caffeinated beverage followed by test caffeinated beverage

OTHER

Other: Participants' typical caffeinated beverage; Other: Test caffeinated beverage

Interventions

Test caffeinated beverage OTHER

Participants will consume a test beverage that contains caffeine.

Participants' typical caffeinated beverage followed by test caffeinated beverage; Test caffeinated beverage followed by participants' typical caffeinated beverage

Participants' typical caffeinated beverage OTHER

Participants will consume the caffeinated beverage they typically consume.

Participants' typical caffeinated beverage followed by test caffeinated beverage; Test caffeinated beverage followed by participants' typical caffeinated beverage

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nlumn LLC: collaborator
• Alethios, Inc.: collaborator
• GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.: lead

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

RECRUITING

Study Officials

• Kristin Nieman, PhD

  Nlumn LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VP Product Innovation, Guayaki Sustainable Rainforest Products

CONTACT

609-799-6067; info@guayaki.com

Alethios, Inc.

CONTACT

650-206-8006; support@alethios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This interventional trial focuses on evaluating the effects of the intervention on health and well-being.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 22, 2026
• Study Start: November 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)