Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
Brief Summary: Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors.

The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population


Options:
A: Inclusion Criteria:

* all adults aged 50-65 years old with Type 2 Diabetes Mellitus
* stable physical condition
* fasting plasma glucose (FPG) concentration ≥7.8mmol/L or 2-h postprandial blood glucose (PG) ≥11.1mmol/L after 75g oral dextrose with an glycated hemoglobin (HbA1c)\>7 %, stable medication.

Exclusion Criteria:

* pregnancy
* breastfeeding
* severe renal or hepatic complications
* treatment by glucocorticoid
* having pancreatic disease or malignancy in recent 3 months
* other factors that may limit adherence to interventions or affect conduct of the trial or participation in another supplementary feeding programme.
B: 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
C: Inclusion Criteria:

* Men and Women (age range 23-64 y)
* BMI of 18-30kg/m2
* Fasting glucose concentration \>5.5 but \<7.5mmol/L
* Total cholesterol \>5.2 but \<7.8mmol/L

Exclusion Criteria:

* medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
* use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis
* exposure to any investigational agent \<42 d before the study
* presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption
* history of substance misuse or alcoholism
* current pregnancy, planned pregnancy, or given birth in the past 12 months
* antibiotic treatment 6 weeks previous to study start date
* allergy or intolerance to intervention breakfast cereals components
* smoking
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