Please select the eligibility criteria that correspond to the clinical trial below.
Title: Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures
Brief Summary: Proposed is a randomized, controlled, modified Latin square parallel design study with two treatment arms to examine walnut consumption effects on diet quality, body composition, and markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A modified crossover design (Latin square)27-29 will allow for both paired and unpaired analyses.


Options:
A: Inclusion Criteria:

* Men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), Thiazolidinediones (TZDs) and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study;
* HbA1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
* Diabetes diagnosed \>6 months prior to randomization
* Weight stable within 3% body weight \>2 months.

Exclusion Criteria:

* Use of acarbose
* Use of Insulin
* Known nut allergies
* Clinically significant gastroparesis
* Use of steroids
* Presence of GI disease (celiac disease, ulcerative colitis, and Crohns)
* Major cardiovascular event (stroke or myocardial infarction)
* Major surgery \< 6 months prior to randomization
* Presence of major debilitating disorder such as clinically significant liver disease (not including non-alcoholic fatty liver (NAFL) or non-alcoholic steatohepatitis (NASH) but including cirrhosis, infectious hepatitis (B and C), aspartate transaminase (AST) or alanine transaminase (ALT) \> 130 IU/L)
* Renal failure (high creatinine \> 150 mmol/L)
* Serum triglyceride \> 6 mmol/L.
* Patients currently undergoing treatment for cancer with the exception of non-melanoma skin cancer, but not high risk patients or those whose treatment has been successfully completed.
B: Inclusion Criteria:

* With metabolic syndrome. Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol \<1.03 for men or \<1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin.
* Being able to comply with the specified feeding conditions
* Being able to eat walnuts
* Being between the ages of 35 and 60 years

Exclusion Criteria:

* Pregnancy or lactation
* Use of insulin
* Severe kidney disease
* Cardiovascular diseases, stroke, cancer and psychological disorders
* Walnut allergies or frequently eating walnuts or other nuts (\>90 grams/week)
* Drug or alcohol abuse.
C: Inclusion Criteria:

* Between 18 and 50 years of age
* Weight stable (\< 3 kg weight change within last 3 months)
* Constant habitual activity patterns (no deviation \> 1x/wk at 30 min/session within last 3 months)
* Constant habitual diet patterns within last 3 months
* Willingness to eat all test foods (peanuts daily for 12 weeks)
* No allergy to foods provided in the study (peanuts)
* Not a daily peanut or tree nut consumer
* Not planning to change use of medications known to influence appetite or metabolism
* Not diabetic or hypertensive
* No history of gastrointestinal pathology
* Non-smoker for one year or more

Exclusion Criteria:

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D: Inclusion Criteria:

* Male and female age 25-75 years;
* Non-smoker;
* High risk for diabetes, defined as meeting at least one of the criteria listed below:

  a. Overweight with increased waist circumference; b.Pre-diabetes: fasting blood glucose \>100mg/dL and \<126mg/dL or HbA1C 5.7-6.4 % c. Metabolic syndrome, i.e. meet three out of five of the following criteria: i.Blood pressure \>130/85 mmHg or currently taking antihypertensive medication; ii. Fasting plasma glucose (FPG) \>100 mg/dL (6.1 mmol/L); iii.Serum triglycerides level (TG)\>150 mg/dL (1.69 mmol/L); iv. High-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1.04 mmol/L) in men, and \< 50 mg/dL (1.29 mmol/L) in women; v. Overweight (BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women.

Exclusion Criteria

* Allergy to walnuts or any other nuts;
* Anticipated inability to complete study protocol for any reason;
* Current eating disorder;
* Restricted diets by choice (i.e., vegetarian, vegan);
* Receiving pharmacotherapy for obesity, including appetite suppressant
* Unstable use of lipid-lowering, antihypertensive medications or aspirin (i.e. dose has changed in the three months prior to enrollment) or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning;
* Regular use of high doses of vitamin E (\>400IU/day) or vitamin C (\>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and fiber supplement unless welling to discontinue supplementation for the study duration.
* Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators);
* Diagnosed diabetes;
* Diagnosed sleep apnea;
* Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis);
* Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin;
* Regular exercise defined as participation in moderate-intensity exercise \> 150 minutes/week.
* Substance abuse (chronic alcoholism, other chemical dependency)
* Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
* Women who get Depo-Provera shots
* Women who are pregnant or lactating
* Women who are currently on hormone replacement therapy
* Substance abuse (chronic alcoholism, other chemical dependency)
* Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)

Answer: D