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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
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Increased non-specific inflammatory markers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 24, 2006
Last Updated
August 1, 2013
Sponsor
German Institute of Human Nutrition
Collaborators
Danone Research Foundation, Leiber Company
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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
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Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome

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