Clinical trial NCT00403689: Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome
Official title: Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Increased non-specific inflammatory markers
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Danone Research Foundation
name: Leiber Company
First posted: 2006-11-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.
timeFrame: 3 days
Secondary outcomes:
measure: Altered gene expression in adipose tissue if changes in primary outcome measures are shown.
timeFrame: 3 days
Other outcomes:
Locations:
city: Nuthetal
country: Germany
facility: German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke
Study officials:
affiliation: German Institute of Human Nutrition
name: Martin O Weickert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Institute of Human Nutrition
name: Andreas FH Pfeiffer, Prof
role: STUDY_CHAIR
References:
citation: Kohl A, Gogebakan O, Mohlig M, Osterhoff M, Isken F, Pfeiffer AF, Weickert MO. Increased interleukin-10 but unchanged insulin sensitivity after 4 weeks of (1, 3)(1, 6)-beta-glycan consumption in overweight humans. Nutr Res. 2009 Apr;29(4):248-54. doi: 10.1016/j.nutres.2009.03.002.