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

3. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Coca-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.
Andre navne:
  • Coke Zero
Aktiv komparator: 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.
Andet: Still 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.
Andre navne:
  • Styring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary concentration of acesulfame potassium (Ace-K)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary metabolomic profile
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to peak urinary acesulfame potassium concentration (Tmax)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Czech University of Life Sciences Prague

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2023

Primær færdiggørelse (Faktiske)

15. juni 2024

Studieafslutning (Faktiske)

30. september 2024

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 155/23 S-IV

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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