NCT00403689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

November 24, 2006

Last Update Submit

August 1, 2013

Conditions

Overweight

Keywords

Increased non-specific inflammatory markers

Outcome Measures

Primary Outcomes (1)

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

    3 days

Secondary Outcomes (1)

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

    3 days

Study Arms (2)

x

EXPERIMENTAL

capsules containing beta glycan

Dietary Supplement: Beta-D-Glucan

y

PLACEBO COMPARATOR

capsules containing placebo (waxy maize starch)

Dietary Supplement: placebo

Interventions

Beta-D-GlucanDIETARY_SUPPLEMENT

1,5 g Beta-D-Glucan daily

x
placeboDIETARY_SUPPLEMENT

1.5 g waxy maize starch daily

y

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects with normal glucose tolerance (NGT)
  • Impaired glucose tolerance (IGT)
  • Impaired fasting glucose (IFG)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nuthetal, 14558, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19410976RESULT

Related Links

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin O Weickert, MD

    German Institute of Human Nutrition

    PRINCIPAL INVESTIGATOR

  • Andreas FH Pfeiffer, Prof

    German Institute of Human Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

DE(1)