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

This study has been completed.

Sponsors and Collaborators: German Institute of Human Nutrition
Danone Research Foundation
Leiber Company
Information provided by: German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT00403689
  Purpose

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.

We hypothesise 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.


Condition Intervention
Overweight
Dietary Supplement: Beta-D-Glucan
Dietary Supplement: placebo

MedlinePlus related topics:   Dietary Supplements   

ChemIDplus related topics:   Insulin    Starch   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Effects of (1,3), (1,6)-Beta-D-Glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome

Further study details as provided by German Institute of Human Nutrition:

Primary Outcome Measures:
  • Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Altered gene expression in adipose tissue if changes in primary outcome measures are shown. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment:   11
Study Start Date:   November 2006
Study Completion Date:   March 2008
Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
x: Experimental
capsules containing beta glycan
Dietary Supplement: Beta-D-Glucan
1,5 g Beta-D-Glucan daily
y: Placebo Comparator
capsules containing placebo (waxy maize starch)
Dietary Supplement: placebo
1.5 g waxy maize starch daily

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy subjects with normal glucose tolerance (NGT)
  • Impaired glucose tolerance (IGT)
  • Impaired fasting glucose (IFG)

Exclusion Criteria:

  • Any severe cardiac
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403689

Locations
Germany
German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke    
      Nuthetal, Germany, 14558

Sponsors and Collaborators
German Institute of Human Nutrition
Danone Research Foundation
Leiber Company

Investigators
Principal Investigator:     Martin O Weickert, MD     German Institute of Human Nutrition    
Study Chair:     Andreas FH Pfeiffer, Prof     German Institute of Human Nutrition    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   German Institute of Human Nutrition, Department of Human Nutrition ( Dr. Martin O. Weickert )
Study ID Numbers:   MOW_bGlucan
First Received:   November 24, 2006
Last Updated:   March 7, 2008
ClinicalTrials.gov Identifier:   NCT00403689
Health Authority:   Germany: Ethics Commission

Keywords provided by German Institute of Human Nutrition:
Increased non-specific inflammatory markers  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Overweight
Insulin

ClinicalTrials.gov processed this record on October 03, 2008




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