30 Participants Needed

Nutritional Supplements for Critical Limb Ischemia

(NutriVasc Trial)

MC
JJ
Overseen ByJeffrey J Siracuse, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Boston Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment Ensure Enlive Advanced Nutrition Shake and similar nutritional supplements for Critical Limb Ischemia?

Research shows that high-calorie, high-protein diets can help with recovery by preventing weight loss and promoting healing in burn patients. Additionally, specialized nutritional support with immunonutrients has been found to reduce complications and hospital stays in surgery patients, suggesting potential benefits for similar conditions.12345

Is the nutritional supplement safe for humans?

The research articles do not provide specific safety data for the nutritional supplements mentioned, but they do discuss their use in various medical conditions, suggesting they are generally considered safe for human use in those contexts.678910

How does the treatment of nutritional supplements for critical limb ischemia differ from other treatments?

This treatment is unique because it involves the use of l-alanyl-glutamine, a specific amino acid combination, administered preoperatively to reduce tissue damage and oxidative stress during surgery for critical limb ischemia, which is not a standard approach in existing treatments for this condition.24111213

What is the purpose of this trial?

A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.

Research Team

JJ

Jeffrey J Siracuse, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Nutritional SupplementExperimental Treatment2 Interventions
Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.

Find a Clinic Near You

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 profile image

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford profile image

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+

Findings from Research

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.
Nutritional evaluation of a blenderized diet in five major burn patients.Bailey, RT., Carnazzo, AJ., Organ, CH.[2019]
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.
[Sipping as a mode of correction of protein-calorie deficiency in intensive care unit patients].Shodiev, IA., Ismailova, ZZ., Kumakhova, AKh., et al.[2008]
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.
Immunonutrition in patients undergoing esophageal cancer resection.Mudge, L., Isenring, E., Jamieson, GG.[2022]

References

Nutritional evaluation of a blenderized diet in five major burn patients. [2019]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Sipping as a mode of correction of protein-calorie deficiency in intensive care unit patients]. [2008]
Immunonutrition in patients undergoing esophageal cancer resection. [2022]
Alpha-ketoglutarate-supplemented enteral nutrition: effects on postoperative nitrogen balance and muscle catabolism. [2019]
The effects of the formula of amino acids enriched BCAA on nutritional support in traumatic patients. [2019]
Provision of high-protein supplement for patients recovering from hip fracture. [2022]
Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. [2019]
Clinical evidence for enteral nutritional support with glutamine: a systematic review. [2022]
Effect of preoperative immunonutrition on body composition in patients undergoing abdominal cancer surgery. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized controlled trial of the influence of the mode of enteral ornithine alpha-ketoglutarate administration in burn patients. [2018]
L-alanyl-glutamine preoperative infusion in patients with critical limb ischemia subjected to distal revascularization reduces tissue damage and protects from oxidative stress. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Immediate postoperative feeding in urological surgery. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
The effect of glutamine supplementation in patients following elective surgery and accidental injury. [2018]
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