Effects of Coca-Cola Zero Sugar Consumption on Urinary Metabolites in Healthy Adults

July 3, 2026 updated by: Jaroslav Havlik, Czech University of Life Sciences Prague

Metabolic Profiling of Acesulfame Potassium After Coca-Cola Zero Sugar Consumption in Healthy Adults

Consumption of beverages containing non-nutritive sweeteners has increased worldwide, but limited information is available regarding the short-term urinary excretion of acesulfame potassium (Ace-K) and the acute metabolic response following consumption of commercially available beverages. This study investigates the urinary pharmacokinetics of Ace-K and the acute urinary metabolomic response after consumption of 500 mL of Coca-Cola Zero Sugar in healthy adults. Participants complete two study arms under free-living conditions: Coca-Cola Zero Sugar and still water (control), separated by a one-month washout period. Urine samples are collected before beverage consumption and repeatedly over the subsequent 24 hours. Proton nuclear magnetic resonance (¹H NMR) spectroscopy is used to quantify Ace-K and other urinary metabolites. The study aims to determine the urinary appearance and elimination kinetics of Ace-K and to identify metabolic changes associated with Coca-Cola Zero Sugar consumption compared with water.

Study Overview

Status

Completed

Detailed Description

Non-nutritive sweeteners (NNS) are widely used as sugar substitutes in reduced-calorie foods and beverages. Among these, acesulfame potassium (Ace-K) is extensively incorporated into commercially available soft drinks because of its high sweetening potency, thermal stability, and minimal caloric contribution. Following oral ingestion, Ace-K is rapidly absorbed and excreted predominantly unchanged in urine, making it a promising biomarker of NNS consumption and dietary exposure. However, limited information is available regarding the urinary pharmacokinetics of Ace-K following consumption of commercially formulated beverages under free-living conditions.

Proton nuclear magnetic resonance (¹H NMR) spectroscopy enables simultaneous quantitative analysis of exogenous compounds and endogenous metabolites in complex biological samples. By applying the same analytical platform to both the intervention beverage and sequential urine samples, this study investigates the relationship between the ingested dose of Ace-K and its urinary excretion profile while simultaneously evaluating short-term metabolic responses following Coca-Cola Zero Sugar consumption.

This non-randomized, within-subject controlled study compares the urinary metabolomic response after consumption of Coca-Cola Zero Sugar with that observed following consumption of still water. The study aims to characterize the urinary appearance and elimination kinetics of Ace-K, quantify pharmacokinetic parameters including time to peak concentration and urinary elimination half-life, and explore acute changes in urinary metabolite profiles associated with Coca-Cola Zero Sugar consumption using quantitative ¹H NMR metabolomics.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Prague
      • Suchdol, Prague, Czechia, 16500
        • Czech University of Life Sciences Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged 18 to 60 years
  • Able and willing to provide written informed consent
  • Willing to consume 500 mL of Coca-Cola Zero Sugar and 500 mL of still water during separate study periods
  • Willing to collect urine samples before and during the 24 hours after each intervention according to the study instructions
  • Willing to avoid foods and beverages containing non-nutritive sweeteners for 48 hours before each study period

Exclusion Criteria:

  • Younger than 18 years or older than 60 years
  • Current smoker
  • Known kidney disease or metabolic disease
  • Regular use of prescription medications
  • Use of antibiotics in last 3 months
  • Consumption of foods or beverages containing non-nutritive sweeteners within 48 hours before either study period
  • Unable or unwilling to comply with the study procedures or urine collection schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coca-Cola Zero Sugar
Participants consumed 500 mL of Coca-Cola Zero Sugar with breakfast. Spot urine samples were collected before beverage consumption and repeatedly over the subsequent 24-hour period for metabolomic and pharmacokinetic analyses using proton nuclear magnetic resonance (¹H NMR) spectroscopy.
Participants consumed a single oral dose of 500 mL Coca-Cola Zero Sugar with breakfast. The intervention beverage was consumed within approximately 10-20 minutes. Spot urine samples were collected before consumption and repeatedly over the subsequent 24-hour period for metabolomic and pharmacokinetic analyses using proton nuclear magnetic resonance (¹H NMR) spectroscopy.
Other Names:
  • Coke Zero
Active Comparator: Still Water
Participants consumed 500 mL of still water with breakfast following a one-month washout period. Spot urine samples were collected before beverage consumption and repeatedly over the subsequent 24-hour period using the same sampling schedule as the Coca-Cola Zero Sugar arm.
Participants consumed a single oral dose of 500 mL still water with breakfast under otherwise comparable conditions following a one-month washout period. Spot urine samples were collected before consumption and repeatedly over the subsequent 24-hour period using the same sampling schedule as the intervention arm.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary concentration of acesulfame potassium (Ace-K)
Time Frame: Baseline and up to 24 hours after beverage consumption
Quantitative measurement of urinary acesulfame potassium (Ace-K) concentration following consumption of 500 mL Coca-Cola Zero Sugar compared with still water, determined by quantitative proton nuclear magnetic resonance (¹H NMR) spectroscopy and used to characterize urinary excretion kinetics.
Baseline and up to 24 hours after beverage consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary metabolomic profile
Time Frame: Baseline and up to 24 hours after beverage consumption
Quantitative analysis of endogenous and exogenous urinary metabolites using proton nuclear magnetic resonance (¹H NMR) spectroscopy to compare metabolomic responses following Coca-Cola Zero Sugar and still water consumption.
Baseline and up to 24 hours after beverage consumption

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to peak urinary acesulfame potassium concentration (Tmax)
Time Frame: Up to 24 hours after beverage consumption
Determination of the time required to reach maximum urinary acesulfame potassium concentration following beverage consumption.
Up to 24 hours after beverage consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available. De-identified data may be considered for sharing upon reasonable request to the study investigators, subject to institutional policies, ethical approval, and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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