Nutritional Optimization for Heart Failure

(ENOL Trial)

Overseen By Melana Yuzefpolskaya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Intubated, congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

Who Is on the Research Team?

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.

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?

Group I: Group 2 (at risk/malnourished) Experimental Treatment 1 Intervention

Patients assessed as at risk for malnourishment or malnourished based on AND-ASPEN criteria automatically assigned to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.

Group II: Group 1 (Not malnourished) - 3 products per day Experimental Treatment 1 Intervention

Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.

Group III: Group 1 (Not malnourished) - 1 product per day Experimental Treatment 1 Intervention

Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 1 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.

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

Abbott Nutrition

Chief Executive Officer since 2020

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 3,375 adults undergoing elective colorectal surgery, preoperative immunonutrition was associated with a lower rate of prolonged hospital stays (13.8% vs 17.3%) compared to those who did not receive it, suggesting it may help reduce complications.

While the overall rate of serious adverse events was not significantly different between the two groups (6.8% vs 8.3%), the findings support the use of immunonutrition as a beneficial intervention in community settings, aligning with previous randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. Thornblade, LW., Varghese, TK., Shi, X., et al.[2019]

In a study of 37 cardiac surgery patients with hemodynamic failure, early enteral nutrition (EN) was found to be feasible and safe, with no serious complications like mesenteric ischemia reported.

Despite the safety of early EN, achieving the targeted energy intake was challenging, as only 40.4% of patients met their energy goals, highlighting the need for careful monitoring of nutritional delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral nutrition in patients with hemodynamic failure following cardiac surgery. Flordelís Lasierra, JL., Pérez-Vela, JL., Umezawa Makikado, LD., et al.[2022]

Laparoscopic procedures enable earlier oral intake after colorectal surgery, which is a key component of enhanced recovery after surgery (ERAS) programs.

Implementing ERAS protocols, such as consuming a carbohydrate-rich beverage before surgery and allowing oral liquid intake on the day of surgery, can lead to reduced postoperative complications and shorter hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current practices of perioperative nutritional therapy in colorectal surgery]. Ohge, H., Okajima, M., Hinoi, T., et al.[2011]

In a study of 45 postoperative patients with esophageal carcinoma, the enteral nutrition formulas Ensure and Nutrison led to faster recovery of gastrointestinal function compared to Peptison, with recovery times of approximately 52.4 and 50.8 hours respectively, versus 60.3 hours for Peptison.

All three nutrition formulas showed similar safety profiles and effectiveness in improving nutritional indices, but Ensure was significantly more cost-effective, costing about 443.3 RMB compared to 639.5 RMB for Nutrison and 990.5 RMB for Peptison.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study of different enteral nutrition formulation treatment after esophagectomy]. Liu, SY., Chen, XF., Wang, F., et al.[2012]

In a study of 215 colon cancer patients, early enteral nutrition (started within 12 hours after surgery) was found to be safe and effective for accelerating recovery compared to starting nutrition after the alimentary canal functions were restored.

The use of a balanced liquid mixture, 'Frezubin,' in early enteral nutrition supports the idea that timely nutritional support can enhance postoperative rehabilitation in colon cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[INFLUENCE TIMING OF THE START OF ENTERAL NUTRITION ON THE IMMEDIATE RESULTS OF SURGICAL TREATMENT OF COLON CANCER]. Mahmudov, DE.[2016]

Preoperative feeding with a carbohydrate-based drink containing glutamine and antioxidants significantly increased liver glycogen reserves by 44% and elevated plasma glutamine and antioxidant levels, with no drink-related complications reported.

The study suggests that the reduction in muscle PDK4 expression in patients receiving the oral nutritional supplement may help explain how this intervention mitigates postoperative insulin resistance, highlighting its potential efficacy in improving metabolic outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Awad, S., Constantin-Teodosiu, D., Constantin, D., et al.[2021]

Citations

1.

abbottnutrition.com

abbottnutrition.com/our-products/ensure-surgery

Ensure® Surgery

Immunonutrition shake. ENSURE SURGERY is specially designed to support immune health and recovery from surgery. For oral use. Use under medical supervision.

2.

withpower.com

withpower.com/trial/nutritional-optimization-for-heart-failure-fc8b4

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 ...

3.

ensure.com

ensure.com/nutrition-products/ensure-surgery

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.

4.

abbottstore.com

abbottstore.com/adult-nutrition/ensure/ensure-surgery/ensure-surgery-immunonutritionshake/ensure-surgery-immunonutrition-shake-vanilla-8-fl-oz-bottle-case-of-24-65047.html?srsltid=AfmBOorRzQPQcPTMkZquNO5ujhvMfOf-no01hYSvkznMle8pXdwiNlL5

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 ...

5.

amazon.com

amazon.com/Ensure-Pre-Surgery-Clear-Carbohydrate-Strawberry/dp/B06WVF2P46

Ensure Pre-Surgery, Clear Carbohydrate Drink ...

Immune-supporting nutrition shake; drink 2-3 shakes per day, 5-7 days before and after surgery.

6.

abbottstore.com

abbottstore.com/adult-nutrition/ensure/ensure-surgery/ensure-surgery-immunonutritionshake/ensure-surgery-immunonutrition-shake-vanilla-8-fl-oz-bottle-case-of-24-65047.html?srsltid=AfmBOorlTgMFGwcvXBXWLDJFSvfpSLspS8cI6RTE2gLiSDdbVgStL5v8

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.

7.

amazon.com

amazon.com/Ensure-Perioperative-Pre-Surgery-Carbohydrate-Immunonutrition/dp/B07ZRG1BQJ

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.