Healthy Adult Participants
Conditions
Keywords
Non-nutritive sweeteners, Acesulfame potassium, Proton NMR spectroscopy, Urinary metabolomics
Brief summary
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.
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.
Interventions
OTHERCoca-Cola Zero Sugar
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.
OTHERStill water
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.
Sponsors
Czech University of Life Sciences Prague
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants completed both interventions in a fixed order separated by a one-month washout period. Coca-Cola Zero Sugar was administered first, followed by still water, with each participant serving as their own control. The order of arms was not randomized; all donors completed the treatment arm first, followed by the control arm after the washout period
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine-normalized urinary acesulfame potassium (Ace-K) concentration (µM/mM creatinine) | 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
| Measure | Time frame | Description |
|---|---|---|
| Creatinine-normalized urinary metabolite concentrations (µM/mM creatinine) | 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. |
Countries
Czechia
Outcome results
None listed