Healthy Adult ParticipantsNCT07694401
Effects of Coca-Cola Zero Sugar Consumption on Urinary Metabolites in Healthy Adults
A study testing Coca-Cola Zero Sugar and Still water in people with Healthy Adult Participants, run by Czech University of Life Sciences Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Coca-Cola Zero Sugar and Still water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- Coca-Cola Zero Sugar, Still water
- Keywords
- Non-nutritive sweeteners, Acesulfame potassium, Proton NMR spectroscopy, Urinary metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coca-Cola Zero SugarOther
Also called Coke Zero
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.
Still waterOther
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Coca-Cola Zero Sugar | Experimental | 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. Receives: Other: Coca-Cola Zero Sugar |
| Still Water | Active comparator | 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. Receives: Other: Still water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine-normalized urinary acesulfame potassium (Ace-K) concentration (µM/mM creatinine)
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.
Measured: Baseline and each scheduled urine collection over 24 hours following beverage consumption.
Secondary outcomes (1)
Creatinine-normalized urinary metabolite concentrations (µM/mM creatinine)
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.
Measured: Baseline and each scheduled urine collection over 24 hours following beverage consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Sep 2023
- Primary completion15 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech University of Life Sciences Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaroslav Havlik, Czech University of Life Sciences Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694401
- Sponsor's protocol ID
- 155/23 S-IV
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profiling of Acesulfame Potassium After Coca-Cola Zero Sugar Consumption in Healthy Adults
- ClinicalTrials.gov ID
- NCT07694401
- Acronym / sponsor ID
- 155/23 S-IV
- Conditions
- Healthy Adult Participants
- Keywords
- Non-nutritive sweeteners, Acesulfame potassium, Proton NMR spectroscopy, Urinary metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Czech University of Life Sciences PragueUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Coca-Cola Zero Sugar | Experimental | Other: Coca-Cola Zero SugarParticipants 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. |
| Still Water | Active comparator | Other: Still waterParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coca-Cola Zero SugarAlso: Coke ZeroParticipants 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 | Coca-Cola Zero Sugar |
| Still waterAlso: ControlParticipants 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 | Still Water |
Primary outcome
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.
1 secondary outcome
Creatinine-normalized urinary metabolite concentrations (µM/mM creatinine)
Time frame: Baseline and each scheduled urine collection over 24 hours following beverage consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coca-Cola Zero Sugar and Still water in people with Healthy Adult Participants, run by Czech University of Life Sciences Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.