Please select the eligibility criteria that correspond to the clinical trial below.
Title: Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
Brief Summary: Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.


Options:
A: Inclusion Criteria:

* Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study
* HbA1c between 6.5 and 8.0% at recruitment
* living within a 40 km radius of St. Michael's Hospital
* Diabetes diagnosed \> 6 months prior to randomization

Exclusion Criteria:

* diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)
* taking insulin or acarbose
* smoking or significant alcohol intake (\> 1 drink/day)
* serum triglycerides \> 4.0 mmol/L
B: Inclusion Criteria:

* impaired glucose tolerance (oral glucose tolerance test with 2-h glucose concentration 7,8-11,0 mmol/l) OR
* impaired fasting glucose fasting plasma glucose concentration 5,6-6,9 mmol/l = IFG)
* and two of the criteria for metabolic syndrome:
* BMI 26-39 kg/m2
* Waist circumference \> 102 cm (men) or \> 88 cm (women)
* hypertriglyceridemia (fasting serum triglyceride conc \> 1,7 mmol/l),
* HDL-cholesterol (fasting serum HDL conc \< 1,0 mmol/l for men and \< 1,3 mmol/l for women)
* Blood pressure ≥ 130/≥ 85 mmHg

Exclusion Criteria:

* BMI \> 40 kg/m2
* fasting serum triglyceride conc \> 3.5 mmol/l
* fasting serum cholesterol \> 8 mmol/l
* type 1 or 2 diabetes
* abnormal liver, kidney or thyroid function
* large alcohol intake (women \>16, men \> 24 doses (4cl liquor or equivalent) during week)
* inflammatory bowel disease
* disease that prevents participation
* neuroleptic neuroleptic cortisone medication
C: Inclusion Criteria:

* 12-15 years
* IsoBMI\>30

Exclusion Criteria:

* Chronical diseases
* Chronical medication
D: Inclusion Criteria:

* body mass index (BMI) ≥ 30
* at least three out of five ATP III criteria for metabolic syndrome. These criteria are defined as: \[1\] Triacylglycerol ≥150 mg/dL, \[2\] HDL \<40 mg/dL in men or \<50 mg/dL in women, \[3\] Fasting glucose ≥100 mg/dL, \[4\] Systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥85 mg/dL, and \[5\] waist circumference ≥102 cm in men or ≥88 cm in women.

Exclusion Criteria:

* diagnosis of type I or II diabetes
* diagnosis of CVD
* diagnosis of cancer
* diagnosis of any other serious medical condition
* use of any medications that affect glucose, insulin, cholesterol, or reproductive hormones
* smoker
* drink more than 2 alcoholic beverages/d
* consume a diet high in whole grains (\>3 servings/d)
* pregnant or lactating

Answer: C