Sucralose Effects on Glucose Metabolism and Gut Microbiota

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Sucralose

• Registration Number: NCT02650947
• Lead Sponsor: Ramathibodi Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-02
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4.
Sucralose	Sucralose	Subjects in this group ate capsule filled with sucralose 200 mg for 4 weeks (week 1-4) and measured oral glucose tolerance test (OGTT), acute insulin response (AIR), and gut microbe examination at week 4.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand