Sucralose Effects on Glucose Metabolism and Gut Microbiota

Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02650947

Enrollment

Registered

2016-01-08

Start date

2016-01-31

Completion date

2017-04-30

Last updated

2017-04-27

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

Conditions

Healthy

Keywords

Sucralose, Insulin Secretion, Insulin Sensitivity, Incretin, Gut Microbiota, Food and Eating Behaviour, Healthy Volunteers

Brief summary

Hypothesis: 1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults. 2. Long-term consumption of sucralose may alter food behaviour in healthy adults.

Detailed description

Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

Interventions

DIETARY_SUPPLEMENTSucralose

Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks

DIETARY_SUPPLEMENTPlacebo

Consumption of empty capsule everyday for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers without underlying disease * Normal oral glucose tolerance test * Agree to participate by written informed consent

Exclusion criteria

* Shift workers * History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test) * Malabsorption problem * Regular consumption of nonnutritive sweeteners * Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3-folds upper normal limit) * Renal impairment (serum creatinine \>1.5 mg/dL) * Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen * Pregnant and lactating woman * Smoking within 6 months

Design outcomes

Primary

Measure	Time frame	Description
The effect of sucralose on insulin secretion	2 hours	We will measure plasma insulin concentrations before and at 0, 2, 3, 4, 5, 6, 8, 10 minutes after administered intravenously 50%glucose 0.3 g/kg within 1 minute. All these data collected were used to calculate acute insulin response to glucose.

Secondary

Measure	Time frame	Description
Glucagon-like peptide-1 secretion	2 hours	—
Gut microbiota	4 weeks	stool exam, polymerase chain reaction for 16s RNA gene using next generation sequencing
Food record	4 weeks	—
The effect of sucralose on insulin sensitivity	2 hours	We will measure plasma insulin concentrations during an oral glucose tolerance test.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026