Nutritional Supplements for Critical Limb Ischemia

(NutriVasc Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey J Siracuse, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Boston Medical Center

Disqualifiers: Pregnancy, Chronic kidney disease, Dialysis

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 4 11 12 13}

Research Team

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.

Trial 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 (Nutritional Supplement)
• Ensure Surgery Immunonutrition Shake (Nutritional Supplement)

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

Group I: Nutritional Supplement Experimental Treatment 2 Interventions

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Medical Center Boston, MA

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Patients Recruited

890,000+

Abbott

Industry Sponsor

Trials

760

Patients Recruited

489,000+

Vascular & Endovascular Surgery Society

Collaborator

Trials

1

Patients Recruited

30+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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 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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Immunonutrition in patients undergoing esophageal cancer resection. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Alpha-ketoglutarate-supplemented enteral nutrition: effects on postoperative nitrogen balance and muscle catabolism. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of the formula of amino acids enriched BCAA on nutritional support in traumatic patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Provision of high-protein supplement for patients recovering from hip fracture. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical evidence for enteral nutritional support with glutamine: a systematic review. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Effect of preoperative immunonutrition on body composition in patients undergoing abdominal cancer surgery. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the influence of the mode of enteral ornithine alpha-ketoglutarate administration in burn patients. [2018]

11. Netherlands 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. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Immediate postoperative feeding in urological surgery. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

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