Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial
Brief Summary: Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.


Options:
A: Inclusion Criteria:

* Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
* CAPscore \>263

Exclusion Criteria:

* Criteria:

  * Taking any kind of antibiotics two weeks before recruitment;
  * History of alcohol consumption ;
  * pregnancy or lactation;
  * Professional athletes;
  * Other liver disease (viral/etc);
  * High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs;
  * A history of Cardiovascular disease;
  * Renal disease, Celiac disease, Cirrhosis;
  * History of Upper Gastrointestinal surgery ;
  * A history of hypothyroidism or Cushing's syndrome;
  * History of drug dependence;
  * Body mass index (BMI) ≥35 kg/m2;
  * A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study;
  * Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
  * Use of weight loss medications
B: Inclusion Criteria:

* Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
* Subjects of both genders from within the Veterans Administration Healthcare System with an age range between 18 to 70 years (inclusive).
* Have type 2 diabetes mellitus as defined by the American Diabetes Association guidelines.
* Female volunteers must be non-lactating and must either be at least one year post-menopausal, or be using adequate mechanical contraceptive precautions (i.e. intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
* The following laboratory values:

  * Hemoglobin at least 12 gm/dl in males or 11 gm/dl in females, WBC count 3,000/mm3 (neutrophil count 1,500/mm3) and platelets 100,000/mm3
  * Albumin equal or greater than 3.0 g/dl
  * Serum creatinine less than 1.8 mg/dl
  * AST and ALT up to 3.0 times upper limit of normal and alkaline phosphatase 2.5 times ULN

Exclusion Criteria:

* Any cause of chronic liver disease other than NASH (such as -but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency).
* Any clinical evidence or history of ascitis, bleeding varices, or spontaneous encephalopathy.
* History of alcohol abuse (alcohol consumption greater than 20 grams of ethanol per day) or a positive AUDIT screening questionnaire.
* Prior surgical procedures to include gastroplasty, jejunoileal or jejunocolic bypass.
* Prior exposure to organic solvents such as carbon tetrachloride.
* Total parenteral nutrition (TPN) within the past 6 months.
* Subjects with type 1 diabetes mellitus.
* Patients on chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for 4 weeks before entry into the study.
* Patients on drugs known to cause hepatic steatosis: estrogens or other hormonal replacement therapy, tamoxifen, raloxifene, oral glucocorticoids, chloroquine and others.
* Patients with a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or diagnosed pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
* Patients with severe osteoporosis (-3.0 at the level of spine and hip).
* Patients who have clinically significant acute or chronic medical conditions not specifically written in the protocol, but that based in the investigator's clinical judgment he/she considers unlikely that he will be able to complete study participation or that such participation may be potentially detrimental to his well-being.
C: Inclusion Criteria:

* BMI \[body weight divided by height squared (in kg/m2)\] \> 23,
* lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
* the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* overuse of alcohol,
* viral hepatitis,
* type 1 or 2 diabetes,
* gastrointestinal or connective diseases,
* chronic pancreatitis,
* liver cirrhosis,
* kidney stones, or renal failure;
* use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
* supplementation with vitamins or antioxidants
D: Inclusion Criteria:

* Liver biopsy consistent with diagnosis of NASH (liver biopsy performed in 3-6 months before enrollment)
* Hyperechogenicity of liver at ultrasound examination
* ALT levels range between normal and \< 10 UNL
* INR \< 1.3
* Albumin \> 3 gr/dl.
* Total bilirubin \< 2.5 mg/dl
* normal renal function
* normal cells blood count
* exclusion of other causes of chronic hepatopathies in children
* Written informed consent to participate in the Protocol by their parents or legal guardians of patients

Exclusion Criteria:

* alcohols or drugs abuse
* use of drugs known to induce steatosis or to affect body weight or carbohydrate metabolism
* autoimmune liver diseases, Wilson's disease, alpha-1-antitripsin deficiency, metabolic liver disease
* every clinical or psychiatric diseases interfering with experimentation according to investigator's evaluation
* finding of active liver disease due to other causes

Answer: C