Sucralose Effects on Glucose Metabolism and Gut Microbiota

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650947
• Other study ID #: 09-58-16
• Status: Completed
• Phase: N/A
• First received: January 2, 2016
• Last updated: April 26, 2017
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Sucralose
Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks
• Placebo
Consumption of empty capsule everyday for 4 weeks

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Ramathibodi Hospital	The Endocrine Society of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

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