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Completed

NCT Number: NCT07694401

Effects of Coca-Cola Zero Sugar Consumption on Urinary Metabolites 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.

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Czech University of Life Sciences Prague

Suchdol, Prague, 16500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Coca-Cola Zero Sugar

Other

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

Still water

Other

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

Primary outcomes

  1. Creatinine-normalized urinary acesulfame potassium (Ace-K) concentration (µM/mM creatinine)

    Time frame: Baseline and each scheduled urine collection over 24 hours following beverage consumption.

    Quantitative measurement of urinary acesulfame potassium (Ace-K) concentration following consumption of 500 mL Coca-Cola Zero Sugar and still water, determined by quantitative proton nuclear magnetic resonance (¹H NMR) spectroscopy. Concentrations will be normalized to urinary creatinine and reported at each scheduled urine collection time point.

Secondary outcomes

  1. Creatinine-normalized urinary metabolite concentrations (µM/mM creatinine)

    Time frame: Baseline and each scheduled urine collection over 24 hours following beverage consumption.

    Quantitative concentrations of individual endogenous and exogenous urinary metabolites measured by quantitative ¹H NMR spectroscopy. Each identified metabolite will be reported separately after normalization to urinary creatinine and compared between Coca-Cola Zero Sugar and still water interventions.

Other outcomes

  1. Area under the urinary acesulfame potassium concentration-time curve (AUC₀-₂₄)

    Time frame: Up to 24 hours after beverage consumption

    Area under the creatinine-normalized urinary acesulfame potassium concentration-time curve calculated using the trapezoidal rule over the 24-hour sampling period.

  2. Concentrations of selected constituents in Coca-Cola Zero Sugar (µg/mL)

    Time frame: Prior to participant consumption (baseline beverage characterization)

    Quantitative concentrations of selected constituents in the intervention beverage, including acesulfame potassium, sodium cyclamate, aspartame, caffeine, citrate, glucose, glycerol, propylene glycol, phenylalanine, and other identified compounds, determined by quantitative proton nuclear magnetic resonance (¹H NMR) spectroscopy. Individual constituents will be reported separately in µg/mL and used to determine the administered dose of beverage components.

Sponsors and collaborators

Lead sponsor

Czech University of Life Sciences Prague

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2026
Registry last updated
Jul 23, 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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