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

HELPS-HD is a pragmatic, cluster randomized clinical trial comparing the effectiveness of two different oral nutritional supplement protocols and accompanying education. All participants in participating facilities will be asked to participate in the study unless they do not qualify. Reflecting the pragmatic study design targeting broad generalizability, inclusion criteria are broad and exclusions are minimal.

The trial compares Usual Care versus an Intensive Nutritional Supplement Protocol. Facilities are cluster randomized into one of two protocols:

1. Usual care protocol which will continue the current nutritional supplement protocol for all patients at the dialysis facility, whereby those with albumin below 3.5 g/dL receive supplement
2. Intensive nutritional supplement protocol, which will prescribe nutritional supplements for all patients at the dialysis facility regardless of serum albumin levels

The majority of DCI facilities currently have the majority of their patients prescribed the usual care oral nutritional supplement protocol, with 20-30% of patients at any given time receiving an in-center oral nutritional supplement based on either incident hemodialysis status or low serum albumin. Of note, all patients are offered the protocol, but approximately 10-20% refuse the protein supplement, often due to taste and individual preference. Being prescribed the protocol does not affect a patient's ability to consume food or other supplements of their choosing before, during (depending on facility and state regulations) or after dialysis; it simply means that they receive an oral nutritional supplement for consumption during dialysis from the dialysis facility included as a part of their routine dialysis care. The specific nutritional supplement is not specified in the protocol, although many facilities currently use Prostat due to pricing and availability. The protocol prescribes approximately 15 g of oral protein supplement; when Prostat is used, this is accomplished by drinking 30 mL of Prostat. In cases of facility or patient preference, including taste fatigue, other supplements can be used in the current usual care protocol in lieu of Prostat. For example, the PI's facility currently has some patients receiving Prostat while others receive BodyQuest Protein Ice Cream, reflecting patient preference. Nutritional supplements utilized during the trial will vary, but should contain approximately 15 g (range 12 to 20 g) of protein with low sodium, potassium and phosphorus content. Based on current use within DCI and availability as well as prior experiences and cost, the following supplements are anticipated:

1. BodyQuest Protein Ice Cream, which contains 16 g of protein and 120 kcal per serving
2. Prostat, Sugar Free, which contains 15 g of protein and 100 kcal per serving
3. LiquaCel Liquid Protein, which contains 16 g of protein and 90 kcal per serving
4. ZonePerfect Nutrition Bars ( flavor varied to avoid taste fatigue), which contain ~ 15 g of protein and ~ 210 kcal per serving
5. Nepro, which contains 19 g of protein and 425 kcal per serving.