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Acute effect of the renally excreted low-calorie sweetener, acesulfame potassium (Ace-K), on urinary glucose excretion in healthy humans.

Acute effect of the renally excreted low-calorie sweetener, acesulfame potassium (Ace-K), on urinary glucose excretion in healthy humans.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000800527
Enrollment
11
Registered
2024-06-28
Start date
2024-04-01
Completion date
2024-07-29
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Low-calorie sweeteners (LCS) have been widely used in food and beverages in recent decades. However, a recent World Health Organisation (WHO) report highlighted that people who consume LCS regularly have an increased risk of developing type 2 diabetes (T2D). Acesulfame potassium (Ace-K) is a widely used low-calorie sweetener that is absorbed from the gut and excreted in the urine. We want to find out whether Ace-K consumption reduces the amount of glucose excreted in the urine in healthy humans.

Interventions

Following enrolment, healthy participants will be studied on 2 occasions, separated by at least 3 days, in a double-blinded, randomised, crossover design. On the evening preceding the study day (~1900h), participants will be given a standardised evening meal (McCain beef Lasagne 400g, 2529 kJ with 66% carbohydrate, 17% protein and 17% fat). Following this meal, participants will be asked to fast from solids and liquids (other than water) until the following morning, when they will attend the Cli

Following enrolment, healthy participants will be studied on 2 occasions, separated by at least 3 days, in a double-blinded, randomised, crossover design. On the evening preceding the study day (~1900h), participants will be given a standardised evening meal (McCain beef Lasagne 400g, 2529 kJ with 66% carbohydrate, 17% protein and 17% fat). Following this meal, participants will be asked to fast from solids and liquids (other than water) until the following morning, when they will attend the Clinical Research Facility of the Adelaide Health and Medical Science building at ~0800h. On each study day, an intravenous cannula will be placed into a vein of each forearm for IV dextrose infusion and blood sampling, respectively. A hyperglycaemic clamp will be maintained at 10 mmol/L from t = 0 to 210 min, by intravenous administration of 25% dextrose. Following an initial 30 min of stabilisation of the hyperglycaemic clamp, participants will be asked to empty their bladder at t = 30 min. Subsequently, participants will consume 250 mL water together with 5 gelatin capsules containing a total dose of (i) 900 mg Ace-K (calculated based on acceptable daily intake at 60 kg of body weight), or (ii) 900 mg cellulose (placebo) at t = 30 min and 250 mL water every 30 min between t = 60 to 180 min respectively, each within 5 min. In both groups, urine samples will be collected every 60 min between t = 30-210 min. The glucose levels in the urine will be measured immediately using a Yellow Springs Instruments (YSI) 2900 analyser. “Arterialised” venous blood will be sampled every 30 min, kept warm with a heating pad, between t = 0 and 210 min for measurement of plasma insulin. Serum creatinine will be measured and used for calculating the estimated Glomerular Filtration Rate (eGFR) by the CKD-EPI formula. Renal artery blood flow will be measured using ultrasound at t = 30 and 210 min. After a final blood sample is collected, participants will be served a light lunch (a sandwich ordered from a Cafe within the building, approximately 350 kcal with 60% carbohydrate, 20% protein and 20% fat; a yoghurt, ~140 kcal with 60% carbohydrate, 30% protein and 10% fat) with water and once the blood concentration has stabilised above 4 mmol/L for 30 min, they will be free to leave the laboratory.

Sponsors

The University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

- Healthy males and females aged from 18 to 70 years - Body mass index (BMI) from 18 to 30 kg/m2 - HbA1c less than 5.7% - Fasting blood glucose less than 5.6 mmol/L

Exclusion criteria

- Habitual use of more than one serve of any food or beverage containing a low-calorie sweetener per day during the past 3 months, ascertained using a low-calorie sweetener frequency questionnaire. - Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis - Haemoglobin below the lower limit of the normal range (ie. < 135 g/L for men and 115 g/L for women), and ferritin below the lower limit of normal (ie. < 30 ng/mL for men and 20 mg/mL for women) - Female participants who are pregnant or planning for pregnancy, or are lactating - History of any form of heart disease or symptoms of syncope or pre-syncope (including feeling lightheaded or dizzy, feeling unsteady when standing, unexplained falls, fainting, unexplained changes in vision, such as blurring or tunnel vision) - Other significant illness, including epilepsy, cardiovascular or respiratory disease - Impaired renal or liver function (as assessed by calculated creatinine clearance less than 60 mL/min or abnormal liver function tests (more than 2 times upper limit of normal range)) - Donation of blood within the previous 3 months - Participation in any other research studies within the previous 3 months - Inability to give informed consent - Vegetarians

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026