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

NCT ID: NCT00403689

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight

Keywords

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Increased non-specific inflammatory markers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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x

capsules containing beta glycan

Group Type EXPERIMENTAL

Beta-D-Glucan

Intervention Type DIETARY_SUPPLEMENT

1,5 g Beta-D-Glucan daily

y

capsules containing placebo (waxy maize starch)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

1.5 g waxy maize starch daily

Interventions

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Beta-D-Glucan

1,5 g Beta-D-Glucan daily

Intervention Type DIETARY_SUPPLEMENT

placebo

1.5 g waxy maize starch daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Research Foundation

UNKNOWN

Sponsor Role collaborator

Leiber Company

UNKNOWN

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Weickert, Martin O.

Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin O Weickert, MD

Role: PRINCIPAL_INVESTIGATOR

German Institute of Human Nutrition

Andreas FH Pfeiffer, Prof

Role: STUDY_CHAIR

German Institute of Human Nutrition

Locations

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

Nuthetal, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 19410976 (View on PubMed)

Related Links

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http://www.dife.de

Related Info

Other Identifiers

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MOW_bGlucan

Identifier Type: -

Identifier Source: org_study_id