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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Beta-D-Glucan; Dietary Supplement: placebo

• Registration Number: NCT00403689
• Lead Sponsor: German Institute of Human Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-24
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
x	Beta-D-Glucan	capsules containing beta glycan
y	placebo	capsules containing placebo (waxy maize starch)

Primary Outcome Measures

Name	Time	Method
Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.	3 days

Secondary Outcome Measures

Name	Time	Method
Altered gene expression in adipose tissue if changes in primary outcome measures are shown.	3 days

Trial Locations

Locations (1)

German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke; 🇩🇪 Nuthetal, Germany