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

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ClinicalTrials.gov Identifier: NCT00403689
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : August 5, 2013
Sponsor:
Collaborators:
Danone Research Foundation
Leiber Company
Information provided by (Responsible Party):
Weickert, Martin O., 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.


Condition or disease Intervention/treatment Phase
Overweight Dietary Supplement: Beta-D-Glucan Dietary Supplement: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : November 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Altered gene expression in adipose tissue if changes in primary outcome measures are shown. [ Time Frame: 3 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
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
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013

Keywords provided by Weickert, Martin O., German Institute of Human Nutrition:
Increased non-specific inflammatory markers

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs