CompletedNot Applicable

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

Czechia10 participantsStarted 2023-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07694401

SponsorCzech University of Life Sciences Prague

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

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