- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00403689
Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nuthetal, Germany, 14558
- German Institute of Human Nutrition, Department of Clinical Nutrition, Potsdam-Rehbrücke
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: x
capsules containing beta glycan
|
1,5 g Beta-D-Glucan daily
|
Placebo Comparator: y
capsules containing placebo (waxy maize starch)
|
1.5 g waxy maize starch daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beta-D-glucan induced changes in inflammatory markers, adipokines, and gut hormones. Changes in insulin-sensitivity.
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Altered gene expression in adipose tissue if changes in primary outcome measures are shown.
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin O Weickert, MD, German Institute of Human Nutrition
- Study Chair: Andreas FH Pfeiffer, Prof, German Institute of Human Nutrition
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOW_bGlucan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Children's Hospital Los AngelesUniversity of Southern California; Tufts Medical CenterRecruitingOverweight and Obesity | Overweight AdolescentsUnited States
-
University of AarhusThe Danish Dairy Research Foundation, Denmark; Sygekassernes HelsefondCompletedOverweight and Obesity | Overweight Adolescents | Metabolic DiseaseDenmark
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
University Hospital Bispebjerg and FrederiksbergUniversity of CopenhagenCompleted
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Khyber Medical University PeshawarRecruitingObesity, OverweightPakistan
-
National Taiwan University HospitalCompleted
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.RecruitingBody Weight | Overweight and ObesityCroatia
Clinical Trials on Beta-D-Glucan
-
Central Hospital, Nancy, FranceCompletedCandidiasis, Invasive | Critically Ill | Intra Abdominal Infections | Peritoneal CandidiasisFrance
-
Medical University of GrazBarmherzige Brueder Marschallgasse / GrazCompleted
-
Imuneks Farma ilac San. Tic. A.S.TC Erciyes UniversityCompleted
-
Oslo Metropolitan UniversityUniversity of Oslo; Nofima; Mills DACompletedGut Microbiota | Satiety | Post Prandial Blood GlucoseNorway
-
Instituto de Ciencia y Tecnología de Alimentos...Ministerio de Economía y Competitividad, SpainCompletedInsulin Resistance | Overweight/ObesitySpain
-
Harokopio UniversityJOTIS S.A. FOOD INDUSTRY, GREECECompleted
-
Fakultas Kedokteran Universitas IndonesiaUnknown
-
University of ManitobaAgriculture and Agri-Food CanadaCompleted
-
University of BergenUniversity of Leipzig; Chalmers University of Technology; Nofima; Paderborn UniversityCompletedHyperglycemia | PreDiabetes | Glycemic Control | BreadNorway
-
University of FloridaLallemand Bio-IngredientsTerminatedAutologous Haemopoietic Stem Cell TransplantUnited States