Metabolic Effects of Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes
NCT01836796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2013-10-25
Summary
Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose concentrations and shows an improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus Gasseri SBT2055 in fermented milk for 12 weeks reduced adiposity and body weight in obese adults possibly by reducing lipid absorption and inflammatory status. However, there are no controlled studies to the investigators knowledge that address whether probiotic supplementation affects glucose metabolism. The investigators hypothesis is that supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2 diabetes patients. In addition, the investigators will explore possible mechanisms behind the antihyperglycemic action of Lactobacillus Reuteri.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Lactobacillus Reuteri
100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.
- DIETARY_SUPPLEMENT
-
Lactobacillus Reuteri DSM17938
Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.
Sponsors & Collaborators
-
BioGaia AB
collaborator INDUSTRY -
Vastra Gotaland Region
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2013-04-30
- Completion
- 2013-07-31
Countries
- Sweden
Study Locations
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