Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function

Study Overview
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Brief Summary
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The aim of the present study is to determine the effect of non-nutritive sweeteners on intestinal barrier function and inflammatory markers in healthy subjects in comparison to mono- and disaccharides.

Detailed Description
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In the intervention study normal weight participants will receive beverages sweetened with non-nutritive sweeteners, mono- and disaccharides for a defined number of days. Before and after intervention parameters of intestinal barrier function will be assessed.

Official Title
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Assessment of the Effects of Non-calorie Sweeteners on Gut Barrier and Inflammatory Markers Compared to Those of Sugars in Healthy Individuals

Conditions
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Dietary Habits, Endotoxemia

Intervention / Treatment
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* Other: Dietary intervention 1
* Other: Dietary Intervention 2
* Other: Dietary Intervention 3
* Other: Dietary Intervention 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No known history of metabolic diseases/disorders BMI <25 kg/m2 Exclusion Criteria: Food allergies or intolerances (esp. fructose intolerance and malabsorption) Chronic disease of the gastrointestinal tract Renal insufficiency Taking drugs affecting lipid or glucose metabolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: All participants receive all interventional diets
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Beverage 1<br>Participants receive a beverage with a defined amount of non-nutritive sweetener. | Other: Dietary intervention 1<br>* Participants receive a beverage with a defined amount of non-nutritive sweetener.<br>|
| Experimental: Experimental: Beverage 2<br>Participants receive a beverage with a defined amount of non-nutritive sweetener. | Other: Dietary Intervention 2<br>* Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.<br>|
| Experimental: Experimental: Beverage 3<br>Participants receive a beverage with a defined amount of monosaccharide. | Other: Dietary Intervention 3<br>* Participants receive a beverage with a defined amount of monosaccharide.<br>|
| Experimental: Experimental: Beverage 4<br>Participants receive a beverage with a defined amount of disaccharide. | Other: Dietary Intervention 4<br>* Participants receive a beverage with a defined amount of disaccharide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parameters of intestinal barrier function. | Changes in plasma endotoxin levels. | 1 week | 
| Changes in inflammatory markers. | Changes in IL-6 plasma levels (ng/ml). | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure. | Changes in systolic and diastolic blood pressure | 1 week | 
| Changes in markers for glucose metabolism. | Changes in fasting glucose (mg/dl) and fasting insulin levels (mU/l) | 1 week | 
| Changes in markers for glucose metabolism. | Changes in fasting insulin levels (mU/l). | 1 week | 
| Changes in blood lipid levels. | Changes in triglyceride levels. | 1 week |