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Clinical Trials/NCT00403689
NCT00403689CompletedNot Applicable

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

German Institute of Human Nutrition1 site in 1 country11 target enrollmentStarted: November 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Any severe cardiac disease
  • •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

Arms & Interventions

x

Experimental

capsules containing beta glycan

Intervention: Beta-D-Glucan (Dietary Supplement)

y

Placebo Comparator

capsules containing placebo (waxy maize starch)

Intervention: placebo (Dietary Supplement)

Outcomes

Primary Outcomes

Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.

Time Frame: 3 days

Secondary Outcomes

  • Altered gene expression in adipose tissue if changes in primary outcome measures are shown.(3 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Weickert, Martin O.

Chief Investigator

German Institute of Human Nutrition

Study Sites (1)

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