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

Effect of regular consumption of non-nutritive sweeteners (artificial sweeteners) on glucose homeostasis in Type 2 diabetic patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000970943
Enrollment
6
Registered
2020-09-28
Start date
2020-08-31
Completion date
2021-12-15
Last updated
2020-10-19

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

Conditions

None listed

Brief summary

Artificial sweeteners, also known as non-nutritive sweeteners (NNS) are used worldwide. A significant proportion of the Australian adult population consume NNS especially those on weight loss diets and by diabetics to control their glycaemia. However, no study till date has evaluated the impact of NNS consumption in diabetic population. The purpose of this study is to investigate the impact of 12 week NNS consumption on blood sugar levels in people with Type 2 diabetes.

Interventions

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

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.

Sponsors

Unievrsity of South Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

• Do not have type 2 diabetes. • Women who are pregnant or breast feeding or wish to become pregnant. • Not a soft drink consumer. • Are allergic to adhesive or have sensitive skin. • Not comfortable to be randomized to any one of the experimental groups.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026