Sucralose Effects on Glucose Metabolism and Gut Microbiota

Study Overview
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Brief Summary
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Hypothesis: Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults. Long-term consumption of sucralose may alter food behaviour in healthy adults.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Sucralose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucralose<br>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<br>* Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks<br>* Other names: Trichlorosucrose;|
| Placebo Comparator: Placebo<br>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<br>* Consumption of empty capsule everyday for 4 weeks<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sucralose, Insulin Secretion, Insulin Sensitivity, Incretin, Gut Microbiota, Food and Eating Behaviour, Healthy Volunteers