Nutritional Supplements for Critical Limb Ischemia

(NutriVasc Trial)

Overseen By Jeffrey J Siracuse, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Boston Medical Center

Disqualifiers: Pregnancy, Chronic kidney disease, Dialysis

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

Compensation: Varies

Number of Visits: 32

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether nutritional shakes can aid individuals with Critical Limb Ischemia (CLI), a condition that blocks blood flow to the limbs. The aim is to determine if these shakes improve nutrition and strength, potentially enhancing recovery after surgery. Participants will consume specific nutrition shakes, such as Ensure Enlive Advanced Nutrition Shake and Ensure Surgery Immunonutrition Shake, and undergo grip strength assessments and lab tests. Individuals with CLI who are not pregnant, not on dialysis, and do not have severe kidney disease may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how these nutritional shakes function in people, offering participants the chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Ensure Enlive Advanced Nutrition Shake and the Ensure Surgery Immunonutrition Shake are safe for use. The Ensure Enlive shake helps people regain muscle strength after surgery or illness. It is a trusted product from a well-known brand and has FDA approval as a nutritional supplement.

The Ensure Surgery shake boosts the immune system and aids recovery after surgery. Rich in protein, it helps repair tissues and heal wounds. Both shakes are intended for oral consumption and should be used under a doctor's guidance, especially for those with special dietary needs.

These shakes have been used without major safety concerns. They are not intended as the sole source of nutrition, so they should be part of a balanced diet. Overall, past use indicates they are well-tolerated and safe for people recovering from medical conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the nutritional supplements, Ensure Enlive Advanced Nutrition Shake and Ensure Surgery Immunonutrition Shake, because they offer a novel approach to addressing critical limb ischemia. Unlike traditional treatments such as revascularization procedures or medications for improving blood flow, these shakes aim to support the body's healing process from the inside by providing targeted nutrients. They are packed with key ingredients that may enhance immune function and promote recovery, offering a potentially less invasive and more supportive option for patients. This nutritional strategy could complement existing therapies, potentially speeding up recovery and improving overall outcomes.

What evidence suggests that these nutritional supplements might be an effective treatment for Critical Limb Ischemia?

Research has shown that nutritional supplements like Ensure Enlive Advanced Nutrition Shake can help maintain and rebuild muscle and strength in patients recovering from illness or surgery. Additionally, Ensure Surgery Immunonutrition Shake supports immune health and recovery after surgery. This trial will evaluate the effects of both Ensure Enlive Advanced Nutrition Shake and Ensure Surgery Immunonutrition Shake on patients with Critical Limb Ischemia (CLI). Studies have found that taking nutritional supplements around the time of surgery can lower the risk of complications and improve recovery in surgical patients. These shakes are designed to provide important nutrients that may improve nutrition and possibly aid in recovery for those with CLI. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey J Siracuse, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with Critical Limb Ischemia (CLI), a severe obstruction of the arteries which drastically reduces blood flow to the extremities, leading to malnutrition. It's not open to pregnant or breastfeeding women, nor those with advanced chronic kidney disease or on dialysis.

Inclusion Criteria

I have severe blockage in my leg arteries causing pain and sores.

Exclusion Criteria

I am currently receiving dialysis.

I am currently pregnant or breastfeeding.

My kidney function is severely reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Nutritional Optimization

Participants receive nutritional supplements to optimize nutritional status before surgery

4 weeks

Weekly visits for nutritional assessment and supplementation

Perioperative Nutritional Supplementation

Participants continue to receive nutritional supplements during the perioperative period

4 weeks

Visits at baseline and 30 days for blood sample collection and nutritional assessment

Follow-up

Participants are monitored for changes in nutritional markers and functional status

4 weeks

2 visits (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Ensure Enlive Advanced Nutrition Shake
• Ensure Surgery Immunonutrition Shake

Trial Overview The study is testing two nutritional shakes: Ensure Surgery Immunonutrition Shake and Ensure Enlive Advanced Nutrition Shake. The goal is to see if these supplements can improve nutrition and physical function in CLI patients before and after vascular surgery.

How Is the Trial Designed?

Group I: Nutritional Supplement Experimental Treatment 2 Interventions

Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

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

Vascular & Endovascular Surgery Society

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study of 82 patients recovering from major soft tissue infections, those who received additional nutrition through sipping hypercaloric formulas showed improved recovery compared to those on a standard diet.

The use of enteral formulas significantly reduced catabolic effects and helped restore protein levels more quickly, indicating their efficacy in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sipping as a mode of correction of protein-calorie deficiency in intensive care unit patients]. Shodiev, IA., Ismailova, ZZ., Kumakhova, AKh., et al.[2008]

In a study of 54 burn patients, enteral administration of ornithine alpha-ketoglutarate (OKG) significantly improved nitrogen balance and wound healing when given as a bolus, with patients healing faster compared to those receiving a soy protein mixture.

The trial suggests that a higher dose of 30 g OKG per day may be more beneficial than 10 g, and it is the first to show that bolus administration is more effective than continuous infusion in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the influence of the mode of enteral ornithine alpha-ketoglutarate administration in burn patients. De Bandt, JP., Coudray-Lucas, C., Lioret, N., et al.[2018]

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]

Glutamine-enriched enteral nutrition is well-tolerated and has been shown to improve immune function in trauma patients, reduce costs in critically ill patients, and alleviate mucositis in patients undergoing chemotherapy, leading to a grade B recommendation for its use.

The review suggests a daily intake of 20 to 30 grams of glutamine, with early initiation and maintenance for at least 5 days, although the optimal dose and duration can vary based on specific medical conditions, resulting in a grade C recommendation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence for enteral nutritional support with glutamine: a systematic review. García-de-Lorenzo, A., Zarazaga, A., García-Luna, PP., et al.[2022]

Preoperative immunonutrition using the immune-enhancing diet product Impact was well tolerated by 40 cancer patients, leading to significant increases in serum retinol-binding protein and arginine levels, which may help the body respond better to surgical stress.

Despite these positive biochemical changes, the study did not find a significant improvement in clinical outcomes after surgery, suggesting that while immunonutrition can induce beneficial changes, it may not directly translate to better recovery or results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of preoperative immunonutrition on body composition in patients undergoing abdominal cancer surgery. Tsujinaka, T., Hirao, M., Fujitani, K., et al.[2018]

Specialized nutritional support with immunonutrients like arginine and omega-3 fatty acids can significantly reduce postoperative complications and hospital stays in elective surgery patients, but its use is not yet standard in esophago-gastric surgery.

Current evidence from small studies on immunonutrition in esophageal cancer surgery is insufficient to recommend routine use, highlighting the need for further research to determine its impact on clinical outcomes in this specific patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunonutrition in patients undergoing esophageal cancer resection. Mudge, L., Isenring, E., Jamieson, GG.[2022]

In a study of 40 patients recovering from abdominal surgery, those receiving amino acid enriched BCAA (branched-chain amino acids) showed a positive nitrogen balance two days earlier than those receiving standard amino acid nutrition, indicating faster recovery.

The BCAA group also experienced greater increases in serum total protein and albumin levels, suggesting improved nutritional status and protein synthesis compared to the standard amino acid group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the formula of amino acids enriched BCAA on nutritional support in traumatic patients. Wang, XY., Li, N., Gu, J., et al.[2019]

In a study of 32 patients with critical limb ischemia undergoing surgery, preoperative infusion of l-alanyl-glutamine (l-Ala-Gln) significantly increased muscle antioxidant capacity and reduced markers of muscle cell damage.

Patients treated with l-Ala-Gln showed improved glucose utilization and lower levels of harmful substances in the blood, indicating potential benefits for muscle recovery during and after ischemic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-alanyl-glutamine preoperative infusion in patients with critical limb ischemia subjected to distal revascularization reduces tissue damage and protects from oxidative stress. Alves, WF., Aguiar, EE., Guimarães, SB., et al.[2015]

Glutamine (GLN) supplementation in patients undergoing elective surgery has been shown to improve nitrogen balance and enhance protein synthesis, particularly in skeletal muscle, which can lead to a shorter hospital stay according to six randomized trials.

In patients with blunt trauma and burn injuries, GLN supplementation increases plasma levels, reduces immunosuppression, and lowers infection rates, highlighting its potential benefits in managing catabolic conditions, although the exact mechanisms are still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of glutamine supplementation in patients following elective surgery and accidental injury. Wilmore, DW.[2018]

In a study of 46 older adults recovering from hip fracture surgery, those who consumed a high-protein supplement (Boost HP) showed a significant improvement in serum albumin levels compared to those on a standard supplement (Ensure), indicating better protein status.

While both supplements were well tolerated and had similar consumption rates, the Boost HP group had a shorter rehabilitation stay (23 days vs. 28 days) and consumed more essential nutrients, suggesting potential benefits of high-protein supplementation in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of high-protein supplement for patients recovering from hip fracture. Neumann, M., Friedmann, J., Roy, MA., et al.[2022]

In a study involving five major burn patients, a high-calorie, high-protein blenderized diet significantly supported their recovery by providing over 60% of their daily caloric needs.

The diet not only prevented significant weight loss but also promoted wound healing and successful skin grafting, making it an effective and cost-efficient nutritional intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional evaluation of a blenderized diet in five major burn patients. Bailey, RT., Carnazzo, AJ., Organ, CH.[2019]

In a study of 32 patients after radical urological surgery, those receiving enteral hyperalimentation with an elemental diet via a Moss tube achieved positive nitrogen balance by 4 days, while those with a nasogastric tube did not.

The Moss tube not only provided effective nutritional support but also helped prevent postoperative paralytic ileus, making it a well-tolerated and cost-effective alternative to parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate postoperative feeding in urological surgery. Seidmon, EJ., Pizzimenti, KV., Blumenstock, FA., et al.[2019]

In a study involving 20 patients who underwent major abdominal surgery, the addition of alpha-ketoglutarate to enteral feeding did not enhance protein metabolism or reduce muscle breakdown compared to standard nutrition.

Both groups experienced a decrease in transthyretin and albumin levels, indicating that neither nutritional approach effectively supported protein status post-surgery, and there were no significant differences in clinical outcomes or nitrogen balance between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpha-ketoglutarate-supplemented enteral nutrition: effects on postoperative nitrogen balance and muscle catabolism. Wirén, M., Permert, J., Larsson, J.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03529019

Nutrition in Patient With Critical Limb Ischemia A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7144819/

Protein and energy supplementation in elderly people at risk ... Evidence for the effectiveness of nutritional supplements containing protein and energy, often prescribed for older people, is limited.

3. abbottnutrition.com abbottnutrition.com/our-products/ensure-enlive-advanced-nutrition-shake

Ensure® Enlive® Advanced Nutrition Shake Specially formulated to help maintain and rebuild lean body mass and strength in patients recovering from illness, injury and surgery. For oral use. For ...

4. nestlemedicalhub.com nestlemedicalhub.com/sites/site.prod.nestlemedicalhub.com/files/2019-09/ACOMPA~1.PDF

IAR vs Ensure Enlive 061616 Approved.xlsx 20. (23% of total kcal). ▻ On a per calorie basis, IMPACT Advanced Recovery® contains. 34% more protein than Ensure® Enlive®. Protein Source. Calcium caseinate ...

5. ftp.cdc.gov ftp.cdc.gov/pub/health_statistics/nchs/dataset_documentation/NHAMCS/doc18-ed-508.pdf

2018 NHAMCS micro-data file documentation This material provides documentation for users of the Emergency Department public use micro-data file of the 2018 National Hospital ...

6. pim.integratedmedsys.com pim.integratedmedsys.com/Brands/Abbott%20Nutrition/PDF/1635878807_EnsurEnliveAdvancedNutritionShakeProductBrochure.pdf

Ensure® Enlive® Advanced Nutrition Shake Safety Precautions l Not for sole-source nutrition. l Not for people with galactosemia. Availability. List Number. Item. 64291. Ensure Enlive Advanced Nutrition ...

7. ensure.com ensure.com/nutrition-products/ensure-enlive-advanced-nutrition-shake/milk-chocolate

Ensure® Enlive Chocolate | Protein Shake for Muscle Health Each bottle of Ensure Enlive, from the #1 doctor-recommended brand* Ensure, provides advanced nutrition with 20 grams of high-quality protein.

8. grovemedical.com grovemedical.com/Customer/grmein/Customerpages/specpages/64283_2023%20Spec%20Sheet.pdf

Ensure Enlive Advanced Therapeutic Nutrition Shake It is specially formulated to help maintain and rebuild lean body mass and strength in patients recovering from illness, injury and surgery. Recommend 2 ...