Pre-Operative Diet for Vascular Disease

Overseen By Charles K Ozaki, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pregnancy, Allergy to Scandi-Shake, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special short-term diet might benefit individuals before major vascular surgery. Participants will either follow a protein-calorie restriction diet using Scandi-Shake (a nutritional supplement) or maintain their usual diet for four days before surgery. The trial aims to assess the diet's practicality and understand its biological effects. It suits individuals planning non-emergency surgery for leg vein issues, who have a year or more to live, and no allergies to the shake ingredients. As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on surgical outcomes.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this pre-operative diet is safe for vascular surgery patients?

Research shows that a short-term diet limiting protein and calories before surgery is generally safe. In a previous study with patients undergoing vascular surgery, participants followed a similar diet for three days without serious side effects, suggesting good short-term tolerance. In the current trial, researchers use a product called Scandi-Shake, mixed with almond milk, to achieve this dietary restriction. While more information is needed about long-term effects, existing research supports the safety of this short-term diet before surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of a pre-operative diet using Scandi-Shake for vascular disease patients. Unlike traditional approaches that focus on medication or surgery alone, this dietary intervention aims to optimize patients' nutritional status right before surgery. By implementing a four-day regimen that restricts calories and protein, researchers hope to enhance surgical outcomes and recovery. This innovative approach could offer a simple yet effective way to improve patient readiness and resilience ahead of surgery.

What evidence suggests that this pre-operative diet is effective for vascular disease?

Research has shown that limiting protein and calories before surgery might improve recovery. In this trial, participants in the experimental arm will follow a short-term diet using Scandi-Shake, involving a four-day dietary intervention immediately before surgery. One study found that patients on a similar diet reduced their calorie intake by about 29.4% and their protein intake by 84.4%. This diet can be safely followed before surgery without major issues. Another study found that special nutrition before surgery helped people with Crohn's disease recover better. These findings suggest that this dietary approach could benefit those undergoing major vascular surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Charles K Ozaki, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for non-emergency lower extremity vein bypass surgery and expected to live at least one more year. They must understand the study, have an albumin level of 3.0 or higher, not be pregnant, and have no allergies to Scandi-Shake ingredients.

Inclusion Criteria

Ability to provide informed consent

Your albumin level is 3.0 or higher, and if it applies to you, you have had a negative pregnancy test.

You are not allergic to any of the ingredients in Scandi-Shake.

Exclusion Criteria

Your albumin level is lower than 3.0.

I had emergency surgery on the blood vessels in my leg.

Doctors think you may live for less than one year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Diet Intervention

Participants follow a 4-day pre-operative dietary intervention with either a protein-calorie restriction diet or an ad libitum diet before elective vascular surgery.

4 days

No in-person visits, diet logging via mobile app

Surgery

Participants undergo elective vascular surgery involving an open major operation.

1 day

Immediate Post-operative Monitoring

Participants are monitored for immediate post-operative outcomes and complications.

1 day

Follow-up

Participants are monitored for safety, effectiveness, and compliance with dietary interventions, including assessment of biological markers and complications.

1 month

Multiple assessments including blood tests and questionnaires

Long-term Follow-up

Participants are monitored for long-term outcomes such as major adverse limb events and survival.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Scandi-Shake

Trial Overview The trial tests a short-term Protein-Calorie Restriction (PCR) diet called Scandi-Shake against a normal diet before elective vascular surgery. It's randomized and controlled, aiming to see if patients will follow the diet at home and how it affects their body before surgery.

How Is the Trial Designed?

Group I: Protein-calorie restriction Experimental Treatment 1 Intervention

Four day dietary intervention immediately before surgery of Scandi-Shake \[any of 4 flavors - vanilla, strawberry, banana cream, and caramel\] mixed with almond milk (85 grams Scandi-Shake mix to 240 cc almond milk) calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on gender, age, height, weight, and activity level.

Group II: Control Active Control 1 Intervention

Ad libitum diet for four days immediately before surgery

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

In the OMEGA-PAD I Trial involving 80 patients with peripheral artery disease, high-dose fish oil supplementation did not significantly improve endothelial function compared to placebo, indicating that it may not be effective for this specific outcome.

However, fish oil supplementation did lead to a significant reduction in triglycerides and an increase in omega-3 fatty acids in the blood, suggesting potential benefits in lipid profiles and inflammation management for patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). Grenon, SM., Owens, CD., Nosova, EV., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8621550/

Short-Term Pre-Operative Protein Caloric Restriction in ... The eight patients enrolled in the PCR arm achieved 29.4% calorie and 84.4% protein restriction on average, and these findings were supported by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9544188/

A retrospective cohort study: pre‐operative oral enteral ... Low‐quality evidence suggests that pre‐operative exclusive enteral nutrition (E/EN) can improve postoperative outcomes in patients with Crohn's disease (CD).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05457881?term=John

Short-Term Endogenous Hydrogen Sulfide Upregulation ... In our own human pilot research, vascular surgery patients have safely completed 3 days of pre-operative PCR diet without serious adverse events or reactions.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/79/NCT03995979/Prot_000.pdf

PI: Salvatore Scali Study Title: Short-Term Dietary Protein ... Diet Modification: Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. They ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/cob.12485

Effect of weight‐loss diets prior to elective surgery on ... This systematic review investigated the effects of weight-loss diets before elective surgery on preoperative weight loss and postoperative ...

6. ppch.pl ppch.pl/article/147953/en

Validity and efficacy of diets used for preoperative weight ... Results: Studies show that even a modest reduction in weight in the early preoperative period facilitates surgery and reduces the number of complications. The ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34836280/

Short-Term Pre-Operative Protein Caloric Restriction in ... In pre-clinical studies, pre-operative restriction of proteins and/or calories (PCR) has been shown to limit ischemia-reperfusion damage, slow ...