Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of an Oral Nutritional Supplement on Nutritional and Functional Status, Biological Markers (Inflammation and Oxidative Stress, Intestinal Microbiota, Circulating microRNA and Its Target Genes) in Malnourished Hemodialysis Patients.
Brief Summary: Malnutrition in hemodialysis patients is frequent and it is associated with a reduction in muscular mass, strength, functional capacity and quality of life, with an increment in inflammatory and oxidative markers, and with a dysregulation of circulating miRNAs and its target genes.

Animal and human studies have reported that some dietary components (macronutrients, micronutrients and other bioactive substances) might restore these altered features.

Thus, we hypothesized that the intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might:

* Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life.
* Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in malnourished hemodialysis patients.

The present study is a randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or individualized diet recommendations, but double-blind to the intake of probiotics. Inclusion criteria comprised adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion and at least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.

The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). A nutritional examination that included anthropometric measurements, handgrip strength measured by a hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA) and a 5 days dietary record; quality of life evaluation by the "12-item short form health survey"; the presence of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale); assessment of functional status by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"; and blood and stool samples will be obtained for each participant in each study visit (except screening visit).


Options:
A: Inclusion Criteria:

* stable dialysis patients able to provide consent.

Exclusion Criteria:-- known g.i. disease

* use of antibiotics for the last two month or expected antibiotic use
* recent hospitalization or other event resulting in instability of food intake
B: Inclusion Criteria:

1. Established type 2 diabetes with at least 6 months diagnosis
2. Age between 30 and 65 years
3. Hb A1c of less than 10% and fasting blood glucose less than 15mmol/l
4. BMI between 18.5-35 kg/ m2
5. Have not on any probiotics for the last 2 months prior to the recruitment
6. Ability to comply to the study protocol
7. They are treated with stabilized dose of medications (either receiving Sulphonylurea or Biguanides or both)

Exclusion Criteria:

1. Pregnancy and lactating (subjects will be excluded if they getting pregnant during course of study)
2. Having advanced diabetes complications except for hypertension and hyperlipidemia
3. Having acute or chronic illness (such as flu, cancer or arthritis rheumatoid) during the study recruitment which may affect carbohydrate metabolism
4. Language barriers which cannot be overcome via available resources
5. Currently being treated with any oral anti-diabetes agents other than Sulphonylurea or Biguanides or being treated with insulin
6. Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase.
C: Inclusion Criteria:

* Adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion.
* At least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.
* Standard hemodialysis therapy (3 days/week, 240 min, high permeability dialyzer, blood flow \>250 ml/min and dialysate flow 500 ml/min) or on-line hemodialysis therapy that was not modified in the last 3 months previous to the inclusion.
* Written informed consent obtained.

Exclusion Criteria:

* Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c\>9%.
* Unstable dry weight.
* Limb amputation.
* Significant edema.
* Active malignancy.
* Hospital admissions in the last 3 months.
* Acute gastrointestinal disease in the 2 weeks before the inclusion.
* Gastrectomy, gastroparesis or abnormal gastric emptying.
* Acute heart failure grade IV.
* Severe hepatic insufficiency (men gamma glutamyl transferase -GGT- \>150 U/l, women \>120 U/l).
* Alcohol or other drugs abuse.
* Participants enrolled in other research study at inclusion.
* Pregnant women.
* No informed consent obtained.
* Patients who received any oral nutritional supplement (specific for hemodialysis patients or not) in the 4 weeks before the inclusion.
* Patients receiving enteral tube feeding.
* Galactosemia, fructosemia, or requirement of a no fiber diet.
* Allergy or hypersensitivity to any ingredient of the oral nutritional supplement.
* Ongoing treatment with glucocorticoids.
* Patients who received any oral fatty acids omega-3 supplement in the 4 weeks before the inclusion.
* Patients who received intradialytic parenteral nutrition in the 3 months before the inclusion.
* Patients who received any probiotics or prebiotics (not as part of the diet) in the 3 months before the inclusion.
* Anemia (Hemoglobin \< 10 g/dl) or Epoetin resistance.
D: Inclusion Criteria:

* Liver cirrhosis
* Active status on the waiting list for liver transplantation
* Confirmed etiology of liver disease

Exclusion Criteria:

* Malignancy
* Human Immunodeficiency Virus infection
* Immunosuppressive treatment prior to liver transplantation
* Cystic fibrosis
* Creatinine clearance rate \< 50 mL/min

Answer: C