Please select the eligibility criteria that correspond to the clinical trial below.
Title: DaVita Assessment of Nutritional Supplement Effects
Brief Summary: This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.


Options:
A: Inclusion Criteria:

* Aged \> 18 years old and ≤70 years old
* Undergone dialysis at least for 6 months.
* Categorised as malnourished based on BMI \<24 kg/m² and serum albumin ≤40 g/L criteria
* No incidence of hospitalisation for past 3 months, free of infection/sepsis and have not undergone surgery for past 6 months.

Exclusion Criteria:

* Patients with high inflammatory diseases, malignancy, cancer
* Vegetarian patients
B: Inclusion Criteria:

1. On hemodialysis for more than 6 months
2. Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \> 1.2)
3. Suboptimal nutritional status identified by:

   * Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:

     * Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months
     * Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight
     * Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:

       * Serum transferrin concentration less than 225 mg/dl
       * Serum prealbumin concentration less than 32 mg/dl

Exclusion Criteria:

1. Active auto-immune, inflammatory or infectious disease
2. Documented malignancy within the last 12 months
3. Patients on unusual dietary restrictions
4. Life-expectancy less than 6 months
5. Inability to tolerate nutritional supplements
C: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient has been on hemodialysis \>6 months at the time of study entry
* Patient dialyzes three times a week
* Patient agrees to try ONS for the 6 month study period.
* Patient has demonstrated an albumin \<3.5 g/dL on last available lab drawn in dialysis facility
* Patient is adequately dialyzed with a Kt/V \> 1.4 at the most recent lab draw
* Patient is capable of reading and comprehending Informed Consent Form and provides written informed consent

Exclusion Criteria:

* Peritoneal dialysis
* Dysphagia
* Aspiration risk
* Difficulty swallowing
* History of symptomatic intolerance to food or liquid consumption during dialysis treatments
* Terminal illnesses with life expectancy \<6 months, e.g. stage IV cancer or full blown AIDS
* Concurrent appetite stimulants
* Use of IDPN in last 3 months
* Inability to follow and to comply with the instructions and guidelines
* Severe liver disease defined as most recent SGOT \> 78
* Active malignancy (other than skin)
* Major surgery within previous 6 months or anticipated during the 90-day study period
* Females who are pregnant or are breast-feeding
* Considered clinically unstable by the treating nephrologists
* Noncompliance with dialysis treatments ( Missed \> 2 treatments in prior month due to noncompliance)
* Extended or frequent hospitalizations defined as hospitalization of longer than 15 days with discharge within the last 30 days or greater than 3 admissions within the last 30 days
* Regular supplement use defined as consumption of \> 7 servings of a commercially available kcal/ protein supplement in the prior month
* Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
D: Inclusion Criteria:

* Patients aged \>18 years, treated by hemodialysis since more than 3 months
* Patients considered to be in a clinical stable state, defined as the absence of acute disease or hospitalization during the last month prior to study begin
* Patients fulfilling the diagnostic criteria of protein energy wasting according to the definition proposed by the International Society of Renal Nutrition and Metabolism (ISRNM)
* Patients having signed the informed consent for the study participation
* Patients covered by medical insurance

Exclusion Criteria:

* Medical contraindication or inability to perform physical exercise
* Inadequate dialysis (KT/V\< 1.2)
* Poor hemodynamic tolerance of dialysis
* Systemic inflammation (CRP \>20 mg/l)
* Pregnancy
* Major trust

Answer: C