Please select the eligibility criteria that correspond to the clinical trial below.
Title: Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial) An Open-Label Cluster Randomized Pragmatic Trial Evaluating the Effectiveness of Oral Intradialytic Nutritional Supplements on Mortality in Hemodialysis Patients
Brief Summary: To conduct a pragmatic randomized clinical trial in which the researchers will determine the mortality impact of a protocol whereby all hemodialysis patients receive an oral, protein-based nutritional supplement during the dialysis procedure as compared to the existing nutritional protocol whereby only hemodialysis patients with serum albumin below 3.5 g/dL and incident hemodialysis patients during the first months of care receive an oral, intradialytic protein-based nutritional supplement during the dialysis procedure.


Options:
A: Inclusion Criteria:

1. Receipt of in-center hemodialysis in a facility participating in the trial
2. Able to consume oral nutritional supplements
3. Age ≥18 years

Exclusion Criteria:

1. Tube feed or intravenous feed dependent
2. Unable to feed oneself or request help with feeding if a supplement is provided
3. Known allergy to ingredient(s) of the supplement
B: 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
C: Inclusion Criteria:

* mean age of 17-65 years old;
* having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment;
* be dialyzed at least 2 times a week for 3 months

Exclusion Criteria:

* hospitalization in the last month;
* active infection;
* using immunosuppressant drugs or multi-vitamins;
* pregnancy, consuming whey or soy products
D: Inclusion Criteria:

* Must receive hemodialysis treatment at least 3 days per week.
* Must be ≥ 30 years of age.
* Must be willing to be randomized to the control or intervention groups.
* Must be physically able to exercise (e.g., no orthopedic problems that would preclude them from cycling during dialysis).
* Must receive medical clearance from their primary care physician to participate.
* Must be on phosphate binders to control calcium levels.

Exclusion Criteria:

* Persistent hemoglobin levels \< 10g/dl.
* Weight greater than 300 pounds.
* Currently receiving any form of intradialytic protein supplementation (oral, enteral, or parenteral) or participating in any form of intradialytic exercise training.
* Chronic obstructive pulmonary disease (COPD) and decompensated chronic heart failure (CHF).
* On dialysis treatment for \< 3 months (or enrollment may be postponed).

Answer: A