- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694401
Effects of Coca-Cola Zero Sugar Consumption on Urinary Metabolites in Healthy Adults
Metabolic Profiling of Acesulfame Potassium After Coca-Cola Zero Sugar Consumption in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Prague
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Suchdol, Prague, Czechia, 16500
- Czech University of Life Sciences Prague
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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:
|
|
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:
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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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 155/23 S-IV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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