Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2.

Fifteen patients with diabetes type 2 have been randomized to

1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
2. a standard diabetes diet as recommended by national health authorities.

The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.


Options:
A: A) Inclusion Criteria:

Eligible participants will be:

1. men, over 50
2. postmenopausal women, over 60 or
3. postmenopausal women under 60 with a family history of hypercholesterolemia and 1 CVD risk factor.

Participants will have the following characteristics:

* BMI 25-40 kg/m2 with body weight that has remained constant (within ±3%) over the last 3 months preceding the onset of the study
* Plus at least 1 of the following 3 criteria:

  1. have type 2 diabetes with one of the following:

     * raised LDL-C(in accordance with the 2012 Canadian Cardiovascular Society Guidelines)
     * raised BP (\> 130/80mmHg), or
     * active smoking;
  2. be non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy; and
  3. have a modified Framingham risk score \>20% (CCS 2012) and are unable (intolerant) or unwilling to take statin drugs.

B) Exclusion Criteria:

Individuals with the following conditions will be excluded:

* cardiovascular disease that precludes exercise e.g.

  * recent stroke or
  * myocardial infarction, or
* cardiac condition that compromises normal function

  * mitral valve disease,
  * heart failure--grades 2-4 (New York Heart Association classification),
  * severe angina or
  * other conditions preventing exercise,
* secondary causes of hypercholesterolemia

  * hypothyroidism, (unless treated and on a stable dose of L-thyroxine)
  * renal or liver disease
* uncontrolled blood pressure
* major disability
* disorder requiring continuous medical attention and treatment:

  * chronic heart failure,
  * liver disease,
  * renal failure or
  * cancer (except non-melanoma skin cancer--basal cell, squamous cell),
* chronic infections (bacterial or viral)
* chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
* other autoimmune diseases
* major surgery \<6 months prior to randomization
* alcohol consumption \>2 drinks/d.
B: Inclusion Criteria:

* Aged 30 and older
* Premenopausal (may be confirmed by FSH)
* No previous diagnosis of cancer (except non-melanomatous skin cancer)
* Body mass index between 25-34 kg/m2
* Women must be expected to live in the Columbus area for the next 18 months.
* All women must present a letter of medical clearance from their primary care physician.

Exclusion Criteria:

* Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
* Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.
* Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
* All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
C: Inclusion Criteria:

* Adults with capacity to perform study
* Diabetes Mellitus Type 2
* C-peptide \> 0
* HbA1C \>5.5
* Unchanged diabetes treatment during last 3 months
* Weight and HbA1C varied less than 5% during last 3 months
* No acute heart disease during last 6 months
* Unchanged treatment with betablocker last 6 months
* Unchanged treatment with thyroid hormone substitution last 6 months

Exclusion Criteria:

* Treatment with insulin
* Chronic treatment with steroids (not inhaled)
* Treatment with Waran (anticoagulant cumarin type)
* Creatinin \> 130 micromol/L
* Elevated liver enzymes (ALAT,ASAT,ALP or GT \> 4 X upper reference value)
* Acute heart disease
* Changed treatment with betablocker or thyroid hormone substitution
D: Inclusion Criteria:

* Age: 18-80 years old.
* Body mass index between 27.5 - 40.
* Steady weight in last 3 months (±3 kg).
* Informed consent provided.

Exclusion Criteria:

* Presence of uncontrolled endocrinological pathology (including hypothyroidism).
* Type 2 diabetes mellitus with bad metabolic control (HbA1c \> 8%).
* Lipid-lowering drugs in the last 3 months.
* Intake of functional foods with plant sterols in the past 6 weeks.
* Vitamin supplements intake.
* Hormone replacement therapy.
* Consumption of Orlistat in the last 2 months
* High intake of alcohol (\> 30 gr./day).
* Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
* Pregnancy or intention of pregnancy during the study.

Answer: C