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Completed

NCT Number: NCT00403689

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke

Nuthetal, 14558, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beta-D-Glucan

Dietary Supplement

1,5 g Beta-D-Glucan daily

Placebo

Dietary Supplement

1.5 g waxy maize starch daily

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. Altered gene expression in adipose tissue if changes in primary outcome measures are shown.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Danone Research Foundation
  • Leiber Company

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 27, 2006
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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