Sucralose Effects on Glucose Metabolism and Gut Microbiota

Ramathibodi Hospital15 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

SucraloseDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Consumption of empty capsule everyday for 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Outcomes

Primary Outcomes

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.

Time frame: 2 hours

Secondary Outcomes

Glucagon-like peptide-1 secretion

Time frame: 2 hours

Gut microbiota

stool exam, polymerase chain reaction for 16s RNA gene using next generation sequencing

Time frame: 4 weeks

Food record

Time frame: 4 weeks

The effect of sucralose on insulin sensitivity

We will measure plasma insulin concentrations during an oral glucose tolerance test.

Time frame: 2 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.