None listed
Conditions
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 pre-diabetes humans.
Interventions
Following enrolment, pre-diabetes participants will be studied on 3 occasions, separated by at least 3 days, in double blinded, randomised, crossover design. On the evening preceding the study day (~1900h), they will be given a standardised evening meal. Following this meal, they will be asked to fast from solids and liquids (other than water) until the following morning, when they will attend the CRF of the AHMS building at ~0800h.
On each study day, an intravenous cannula will be placed into
Following enrolment, pre-diabetes participants will be studied on 3 occasions, separated by at least 3 days, in double blinded, randomised, crossover design. On the evening preceding the study day (~1900h), they will be given a standardised evening meal. Following this meal, they will be asked to fast from solids and liquids (other than water) until the following morning, when they will attend the CRF of the AHMS 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 13 mmol/L from t = -30 to 120 min, by intravenous administration of 25% dextrose. Participants will consume 6 gelatin capsules containing a total dose of (i) 1050 mg Ace-K (calculated based on ADI at 70 kg of body weight), (ii) 350 mg sucralose (of equal sweetness to the dose of Ace-K) or (iii) 1050 mg cellulose (placebo) at t = 0 min and 250 mL water every 30 min between t = 30 to 90 min respectively, each within 5 min. Following an initial 30 min of stabilisation of the hyperglycaemic clamp, participants will be asked to empty their bladder at t = 30 min. Urine samples will be collected every 60 min between t = 30-150 min. The glucose levels in the urine will be measured immediately using a YSI analyser. “Arterialised” venous blood will be sampled every 30 min, kept warm with a heat pad, between t = 0 and 150 min in pre-diabetes group, for measurement of plasma insulin. After a final blood sample is collected, participants will be served with 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 pre-diabetes participants, they will be free to leave the laboratory. The total amount of blood drawn during the screening and study visits will be ~200 mL for pre-diabetes participants.
Sponsors
Adelaide University
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 70 Years
Healthy volunteers
No
Inclusion criteria
- Fasting plasma glucose 5.6-6.9 mmol/L, 2-hour plasma glucose at a 75g OGTT 7.8-11.0 mmol/L, or HbA1c 5.7%-6.4% - Males and females, aged 18-70 years - Body mass index (BMI) 20 - 40 kg/m2
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