Overview

This trial is active, not recruiting.

Condition healthy
Treatments sucralose, placebo
Sponsor Ramathibodi Hospital
Collaborator The Endocrine Society of Thailand
Start date January 2016
End date March 2017
Trial size 15 participants
Trial identifier NCT02650947, 09-58-16

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
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.
sucralose Trichlorosucrose
Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks
(Placebo Comparator)
Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4.
placebo
Consumption of empty capsule everyday for 4 weeks

Primary Outcomes

Measure
The effect of sucralose on insulin secretion
time frame: 2 hours

Secondary Outcomes

Measure
Glucagon-like peptide-1 secretion
time frame: 2 hours
Gut microbiota
time frame: 4 weeks
Food record
time frame: 4 weeks
The effect of sucralose on insulin sensitivity
time frame: 2 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult
Principal investigator Chutintorn Sriphrapradang, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ramathibodi Hospital.