50 Participants Needed

Nutritional Optimization for Heart Failure

(ENOL Trial)

AL
MY
Overseen ByMelana Yuzefpolskaya, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Ensure Surgery Immunonutrition shake can benefit individuals with severe heart failure who are about to receive a heart pump device, known as an LVAD. Researchers seek to discover whether consuming this shake before surgery can enhance gut health, reduce inflammation, and decrease complications such as infections or prolonged hospital stays. Participants will be grouped based on nutritional needs, with some consuming the shake once daily and others three times daily, to identify the most effective regimen. The trial is suitable for hospitalized patients preparing for LVAD surgery who are either well-nourished or at risk of malnutrition. As an unphased trial, it offers a unique opportunity to contribute to understanding how nutrition can affect surgical outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nutritional intervention is safe for heart failure patients?

Research shows that the Ensure Surgery Immunonutrition shake supports the immune system and aids recovery after surgery. This drink contains protein, arginine (an amino acid), and omega-3s, which help the body heal. Studies have found that these ingredients are usually well-tolerated and beneficial for post-surgery recovery.

A doctor should supervise the use of the shake, monitoring progress to quickly address any side effects. No reports of serious side effects have emerged, making it a safe choice for many preparing for surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the Ensure Surgery Immunonutrition shake because it offers a nutritional approach to support heart failure patients, particularly those undergoing LVAD implantation. Unlike standard heart failure treatments like medications or surgical interventions that primarily target heart function, this shake focuses on optimizing nutritional status. It's packed with essential nutrients and designed to boost immune function and recovery. This is especially important for malnourished patients, who receive a higher dosage, as good nutrition can significantly impact surgical outcomes and overall health.

What evidence suggests that Ensure Surgery Immunonutrition shake might be an effective treatment for heart failure?

Research has shown that the Ensure Surgery Immunonutrition shake can support the immune system and aid recovery after surgery. This shake contains 18 grams of high-quality protein, which helps repair tissues and heal wounds. It also includes omega-3 fatty acids, such as EPA and DHA, which can reduce swelling. Studies have found that reducing swelling and improving nutrition can lead to better surgical outcomes, including fewer infections and shorter hospital stays. In this trial, well-nourished participants will receive either 1 or 3 shakes per day, while those at risk for malnourishment or who are malnourished will receive 3 shakes per day. Although specific data for heart failure patients with LVADs is limited, the shake's ingredients are known to support overall recovery and health.12467

Who Is on the Research Team?

MY

Melana Yuzefpolskaya, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced heart failure who are hospitalized and awaiting LVAD implantation. They must be able to eat by mouth and not have congenital heart disease, infiltrative cardiomyopathy, or require intubation. Surgery should not be expected within the next 5 days.

Inclusion Criteria

I am currently receiving LVAD therapy.
I am currently in the hospital.
I am older than 18 years.

Exclusion Criteria

I was born with a heart condition.
My surgery is scheduled within the next 5 days.
I am currently on a breathing machine.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Nutritional Intervention

Participants receive Ensure Surgery Immunonutrition shake to optimize nutritional status before LVAD implantation

Approximately 5 days
Daily monitoring

Surgery and Immediate Post-operative

Participants undergo LVAD implantation and are monitored for immediate post-operative outcomes

Approximately 25 days
In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after discharge, including changes in biomarkers and microbiome

Approximately 30 days post-discharge
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Ensure Surgery Immunonutrition shake
Trial Overview Researchers are testing if drinking Ensure Surgery Immunonutrition shake before surgery can improve gut health, reduce inflammation, and decrease complications after getting an LVAD. Malnourished patients will drink it three times a day while well-nourished ones will be randomly chosen to drink once or thrice daily.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Group 2 (at risk/malnourished)Experimental Treatment1 Intervention
Group II: Group 1 (Not malnourished) - 3 products per dayExperimental Treatment1 Intervention
Group III: Group 1 (Not malnourished) - 1 product per dayExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Abbott Nutrition

Industry Sponsor

Trials
173
Recruited
33,700+
Robert B. Ford profile image

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz profile image

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University

Published Research Related to This Trial

In a study of 570 heart failure inpatients, the use of oral nutrition supplements (ONS) was linked to a higher length of stay (LOS) in the hospital, with an odds ratio of 2.43, suggesting that ONS alone may not effectively reduce LOS.
Factors such as comorbidity, discharge destination, and dietitian consultations also influenced LOS, indicating that a comprehensive approach is needed to improve care and reduce hospital stays for heart failure patients.
Oral nutritional supplement use in relation to length of stay in heart failure patients at a regional medical center.Babb, EB., Rohrer, J.[2022]
In a study of 60 patients undergoing open colorectal surgery, preoperative carbohydrate (CHO) drinks significantly reduced postoperative neutrophil-to-lymphocyte ratio (NLR) values, indicating a lower inflammatory response compared to those who fasted before surgery.
The CHO group experienced no major postoperative complications, while the fasting group had a higher incidence of severe complications, suggesting that preoperative carbohydrate loading may enhance recovery and reduce surgical stress.
Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications following Colorectal Cancer Surgery: A Randomized Controlled Study.Rizvanović, N., Nesek Adam, V., Kalajdžija, M., et al.[2023]
A study involving 20 healthy volunteers found that a clear carbohydrate drink (CCD) empties from the stomach significantly faster than two types of oral nutritional supplements (ONS), indicating that gastric emptying is influenced more by nutrient load than by volume or viscosity.
The results suggest that it is safe to administer the CCD just 2 hours before surgery, while the ONS drinks should be given at least 3 hours prior to ensure proper gastric emptying.
Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study.Lobo, DN., Hendry, PO., Rodrigues, G., et al.[2009]

Citations

Ensure® SurgeryImmunonutrition shake. ENSURE SURGERY is specially designed to support immune health and recovery from surgery. For oral use. Use under medical supervision.
Nutritional Optimization for Heart Failure (ENOL Trial)Trial Overview Researchers are testing if drinking Ensure Surgery Immunonutrition shake before surgery can improve gut health, reduce inflammation, and decrease ...
Ensure® Surgery Drink | Liquid Diet After ...Learn about Ensure Surgery Immunonutrition vanilla shake, specially designed to support immune health and recovery when added to your diet after surgery.
Ensure Surgery Immunonutrition Shake / Vanilla / 8 fl oz ...Ensure Surgery immunonutrition shake contains 18 grams of high-quality protein to support tissue repair and wound healing. It also has EPA & DHA (omega-3 ...
Ensure Pre-Surgery, Clear Carbohydrate Drink ...Immune-supporting nutrition shake; drink 2-3 shakes per day, 5-7 days before and after surgery.
Ensure Surgery Immunonutrition Shake / Vanilla / 8 fl oz ...Ensure Surgery has EPA & DHA, arginine, 18g protein for tissue repair, and is high in protein and fish oil, supporting immune health and surgical recovery.
Ensure Surgery Perioperative 5-Day Bundle with 3 ...A high-protein nutrition shake with arginine + fish oil to support immune health and surgical recovery. Drink2-3 shakes per day for 5-7 days before surgery.
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