Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Beta-D-Glucan
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Increased non-specific inflammatory markers
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
Sites / Locations
- German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
x
y
Arm Description
capsules containing beta glycan
capsules containing placebo (waxy maize starch)
Outcomes
Primary Outcome Measures
Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.
Secondary Outcome Measures
Altered gene expression in adipose tissue if changes in primary outcome measures are shown.
Full Information
NCT ID
NCT00403689
First Posted
November 24, 2006
Last Updated
August 1, 2013
Sponsor
German Institute of Human Nutrition
Collaborators
Danone Research Foundation, Leiber Company
1. Study Identification
Unique Protocol Identification Number
NCT00403689
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
Danone Research Foundation, Leiber Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Increased non-specific inflammatory markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
x
Arm Type
Experimental
Arm Description
capsules containing beta glycan
Arm Title
y
Arm Type
Placebo Comparator
Arm Description
capsules containing placebo (waxy maize starch)
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-D-Glucan
Intervention Description
1,5 g Beta-D-Glucan daily
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
1.5 g waxy maize starch daily
Primary Outcome Measure Information:
Title
Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Altered gene expression in adipose tissue if changes in primary outcome measures are shown.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin O Weickert, MD
Organizational Affiliation
German Institute of Human Nutrition
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas FH Pfeiffer, Prof
Organizational Affiliation
German Institute of Human Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke
City
Nuthetal
ZIP/Postal Code
14558
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19410976
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.
Results Reference
result
Links:
URL
http://www.dife.de
Description
Related Info
Learn more about this trial
Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome
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