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

This study has been completed.
Sponsor:
Collaborators:
Danone Research Foundation
Leiber Company
Information provided by (Responsible Party):
Weickert, Martin O., German Institute of Human Nutrition
ClinicalTrials.gov Identifier:
NCT00403689
First received: November 24, 2006
Last updated: August 1, 2013
Last verified: August 2013
  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.

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome

Resource links provided by NLM:


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
Experimental: x
capsules containing beta glycan
Dietary Supplement: Beta-D-Glucan
1,5 g Beta-D-Glucan daily
Placebo Comparator: y
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 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
  Contacts and Locations
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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

Additional Information:
Publications:
Responsible Party: Weickert, Martin O., Chief Investigator, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT00403689     History of Changes
Other Study ID Numbers: MOW_bGlucan
Study First Received: November 24, 2006
Last Updated: August 1, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Overweight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014