Human Faecal Microbiota in Type 2 Diabetes
Type 2 Diabetes, Healthy, Overweight
About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring diabetes mellitus type 2, healthy subjects, human microbiome, cereal bar
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Lean non diabetic
Overweight non diabetic
Overweight diabetic
Lean and healthy subjects receiving no intervention
fiber rich cereal bars, two bars a day for 4 weeks
fiber rich cereal bars, two bars a day for 4 weeks