Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome

Study Overview
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Brief Summary
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Insoluble (1,3),(1,6)-beta-D-glucan from bakers yeast are indigestible polysaccharides. Previous studies indicate that the intake of insoluble dietary fiber is strongly associated with reduced risk of type 2 diabetes and cardiovascular disease. However, the mechanisms leading to this phenomenon are largely unknown. There are close relations between metabolic and inflammatory pathways, and a number of hormones, cytokines, signal proteins, bioactive lipids, and transcription factors have been shown to be involved in both systems. Beta-D-glucans have been suggested to play a role as so called biological response modifiers. Studies in animals indicate that even small doses of (1,3),(1,6)-beta-D-glucan may have beneficial effects on immune activity, i.e., by reducing the secretion of inflammatory factors. The investigators hypothesize that the intake of isolated (1,3), (1,6)-beta-D-glucan from bakers yeast improves inflammatory makers and insulin-sensitivity in overweight subjects with increased C-reactive protein concentrations at baseline.

Official Title
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Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Beta-D-Glucan
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects with normal glucose tolerance (NGT) Impaired glucose tolerance (IGT) Impaired fasting glucose (IFG) Exclusion Criteria: Any severe cardiac disease Liver Kidney diseases Type 1 or type 2 diabetes Chronical and acute inflammatory diseases Lipid lowering drugs Cortisone Antibiotics Non-steroidal antiinflammatory drugs Including low dose acetylsalicylic acid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: x<br>capsules containing beta glycan | Dietary Supplement: Beta-D-Glucan<br>* 1,5 g Beta-D-Glucan daily<br>|
| Placebo Comparator: y<br>capsules containing placebo (waxy maize starch) | Dietary Supplement: placebo<br>* 1.5 g waxy maize starch daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Altered gene expression in adipose tissue if changes in primary outcome measures are shown. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Increased non-specific inflammatory markers