Human Faecal Microbiota in Type 2 Diabetes
Human Faecal Microbiota in Type 2 Diabetes
The main objective of the clinical trial is to investigate whether overweight type 2 diabetic
 patients have a different fecal microbiota profile compared with age, gender, BMI matched
 subjects and with lean healthy subjects before and after the consumption of fiber rich cereal
 bars.
Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The
 diversity and quantity of bacteria vary depending on age of the individuals, daily diet and
 the segment of the intestine, which makes the gut microbiota one of the most complex
 bacterial ecosystems known to men. In general, over trillions of bacteria reside in human
 gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by
 multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat
 storage or obesity has become one of the leading public health issues in many developed and
 developing countries. However, it is not clear whether type 2 diabetes is associated with a
 unique gut microbiota profile. Therefore, the primary objective of the study is to compare
 the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI
 matched subjects as well as with lean non-diabetic subjects. In addition, the investigators
 hypothesize that microbiota modifications with consumption of fiber rich food products can
 improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the
 investigators plan to provide each overweight participant with two cereal bars per day for 4
 weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will
 be determined.
Inclusion Criteria:

 -All diabetic and control non-diabetic subjects (of same BMI) must comply with all the
 following inclusion criteria:

 -  Ethnic background: Caucasian

 -  BMI: 25 to 40 kg/m2

 -  Fasting blood glucose > 7 mmol/L

 -  Fasting Hemoglobin A1c > 7%

 -  Consume mainly typical Western diets daily

 -  Having obtained his/her informed consent

 Lean non-diabetic healthy subjects must comply with the following inclusion criteria:

 -  Ethnic background: Caucasian

 -  BMI: 20 to 25 kg/m2

 -  Fasting blood glucose < 5.5 mmol/L

 -  Fasting Hemoglobin A1c < 6 %

 -  Consume mainly typical Western diets daily

 -  Having obtained his/her informed consent

 Exclusion Criteria:

 Diabetic and healthy (same BMI) subjects representing one or more of the following criteria
 are excluded from participation in the study.

 -  Dietary supplements or medications known to alter gut bacteria, such as antibiotic
 medication or intestinal transit modulators

 -  People actively take cortisol or dexamethasone should be excluded from the study

 -  People under a-amylase/a-glucosidase inhibitors should be excluded from the study.
 However, patients under metformin can be accepted for this study.

 -  Patients under metformin suffering from gastrointestinal side effects within a 6-month
 time period prior to the trial

 -  Regular consumption of fermented dairy products

 -  Vegetarians

 -  Frequent diarrhea (more than two loose stool per day) within 7 days before the
 enrollment

 -  HIV seropositive

 -  Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease,
 peptic ulcers and cancer

 -  Patients who cannot be expected to comply with treatment

 -  Currently participating or having participated in another clinical trial during the
 last 6 months prior to the beginning of this study

 -  Females with hormone therapy will be excluded from the study

 Lean healthy subjects representing one or more of the following criteria are excluded from
 participation in the study.

 -  Dietary supplements or medications known to alter gut bacteria, such as antibiotic
 medication or intestinal transit modulators

 -  Regular consumption of fermented dairy products

 -  Vegetarians

 -  Frequent diarrhea (more than two loose stool per day) within 7 days before the
 enrollment

 -  HIV seropositive

 -  Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease,
 peptic ulcers and cancer

 -  Patients who cannot be expected to comply with treatment

 -  Currently participating or having participated in another clinical trial during the
 last 6 months prior to the beginning of this study

 -  Females with hormone therapy will be excluded from the study