Metabolic Effects of Non-nutritive Sweeteners

Study Overview
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Brief Summary
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The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar.

Detailed Description
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The investigators of this study have recently found that sucralose, the most commonly used non-nutritive sweetener (NNS), affects the glycemic response to an oral glucose tolerance test (OGTT) and potentiates glucose-stimulated insulin secretion in obese people who are not regular consumers of NNS. However, studies conducted in healthy lean adults, none of which control for previous use of NNS, show that sucralose does not affect glycemic or hormonal responses to the ingestion of glucose or other carbohydrates. Therefore, we do not know a) whether sucralose effects are limited to obese subjects, or are generalizable to lean people when controlling for prior history of NNS consumption, and b) mechanism(s) responsible for the acute effect of sucralose on glucose metabolism as we measured in obese subjects. The aim of this study is to determine the effects of an acute intake of sucralose on the metabolic response to an oral glucose tolerance test in lean and obese people.

Official Title
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Metabolic Effects of Non-nutritive Sweeteners

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Sucralose
* Other: Water
* Dietary Supplement: glucose load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 30 kg/m2 or BMI ≥ 18 kg/m2 and BMI<25 kg/m2 insulin sensitive: based on the homeostasis model assessment of insulin resistance (HOMA-IR) <3 Exclusion Criteria: BMI ≥ 25 kg/m2 and BMI<30 kg/m2 HOMA-IR>3 Current smoker or quit smoking less than 6 months ago pregnancy or breastfeeding subjects who have malabsorptive syndromes, phenylketonuria, inflammatory intestinal disease, liver or kidney diseases, diabetes subjects who are taking any medication that might affect metabolism anemia regular use of non-nutritive sweeteners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drink Sucralose<br>Subjects will drink sucralose 10 min before drinking a glucose load | Dietary Supplement: Sucralose<br>* 60 ml of 2mM sucralose<br>Dietary Supplement: glucose load<br> <br> |
| Placebo Comparator: Drink Water<br>Subjects will drink water 10 min before drinking a glucose load | Other: Water<br>* 60 ml of water<br>Dietary Supplement: glucose load<br> <br> |
| Experimental: Taste and spit Sucralose<br>Subjects will taste and spit up sucralose 10 min before drinking a glucose load | Dietary Supplement: Sucralose<br>* 60 ml of 2mM sucralose<br>Dietary Supplement: glucose load<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak insulin secretion rate | Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin and C-peptide. Insulin secretion rate will be assessed using the minimal model of Breda and collaborators. | up to 5 hours after drinking a glucose load | 
| Glucose rate of appearance | Blood samples will be collected before and for 5 hours after drinking a glucose load to determine glucose and glucose tracer:tracee ratios. | up to 5 hours after drinking a glucose load | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose-dependent insulinotropic polypeptide (GIP) | Blood samples will be collected before and for 5 hours after drinking a glucose load to determine GIP. | up to 5 hours after drinking a glucose load | 
| Sucralose concentrations in plasma | Sucralose concentrations in plasma will be measured by using liquid chromatography-mass spectrometry. | up to 310 min after drinking the sucralose load | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sucralose