Sucralose Effects on Glucose Metabolism and Gut Microbiota

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Sucralose; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Faculty of Medicine Ramathibodi Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Sucralose; Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks; Other Names: Trichlorosucrose
Placebo Comparator: Placebo; Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4.	Dietary supplement: Placebo; Consumption of empty capsule everyday for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ramathibodi Hospital
• Collaborators: The Endocrine Society of Thailand
• Investigators: Principal Investigator: Chutintorn Sriphrapradang, M.D., Ramathibodi Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: January 2, 2016
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Insulin Sensitivity; Gut Microbiota; Incretin; Insulin Secretion; Sucralose; Food and Eating Behaviour
• Other Study ID Numbers: 09-58-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided