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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403689
• Other study ID #: MOW_bGlucan
• Status: Completed
• Phase: N/A
• First received: November 24, 2006
• Last updated: August 1, 2013
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: August 2013
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Overweight

Intervention

Dietary Supplement:
• Beta-D-Glucan
1,5 g Beta-D-Glucan daily
• placebo
1.5 g waxy maize starch daily

Locations

Country	Name	City	State
Germany	German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke	Nuthetal

Sponsors (3)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Danone Research Foundation, Leiber Company

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kohl A, Gögebakan O, Möhlig M, Osterhoff M, Isken F, Pfeiffer AF, Weickert MO. Increased interleukin-10 but unchanged insulin sensitivity after 4 weeks of (1, 3)(1, 6)-beta-glycan consumption in overweight humans. Nutr Res. 2009 Apr;29(4):248-54. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.		3 days	No
Secondary	Altered gene expression in adipose tissue if changes in primary outcome measures are shown.		3 days	No

External Links

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