Effect of regular consumption of artificial sweetener on blood glucose levels in Type 2 diabetic patients

Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: This will be a randomized parallel design study and participants will be randomized to consume daily either 1. 600 ml artificially sweetened soft drink (acelfame K+ aspartame) 2. 600 ml sugar sweetened soft drink and 3. 600ml soda water for 12 weeks. Arm 1: Artificially sweetened soft drink Arm 2: Regular soft drink Arm 3: Soda water The average artificial sweetener content in the artificially sweetened drink is approximately 147mg aspartame and 79mg acelfame K per 600ml drink (arm 1). The average sugar content in regular soft drink is approximately 57g/600ml drink (arm 2). The participants can consume 600 ml of the test product (depending upon their respective allocation) any time of the day depending on their choice/convenience. All the drinks will be provided to the participants. To monitor compliance, the participants will be asked to complete a daily drink record sheet to record the quantity of drink consumed and to bring the empty bottles back. CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Metabolic and Endocrine ‐ Diabetes Type 2 Diabetic ; ; Type 2 Diabetic PRIMARY OUTCOME: Daily average glucose measured with continuous glucose monitor (CGM) as percentage time above 10 mmol/L [2 week and 12 week post‐ intervention commencement] SECONDARY OUTCOME: Change in HbA1c from baseline [At Baseline and at 12 weeks post intervention] Change in weight from baseline using a calibrated digital weighing scale.[At Baseline and at 12 week post intervention] INCLUSION CRITERIA: • Age> 18 years, Both men and women. Not pregnant or breast‐feeding females only. • Type 2 diabetic with blood sugar controlled with diet or medication of any type. • Current soft drink user but ready to switch to soda water or artificially sweetened beverages. • No known allergies/intolerances to the artificial sweeteners. • No consumption in the last 2 weeks of ASB or regular NNS consumption in other food forms • Agreeable to consuming 600 ml daily artificially sweetened soft drink or regular soft drink or soda water daily for 12 weeks. • Willing to wear a continuous glucose monitoring system and scan the sensor at least 4 times/day.
Epistemonikos ID: c60dbb9414e87f9ea38cf57105ad040bacfe824a
First added on: Aug 24, 2024