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Dietary Supplement
Pre-Operative Diet for Vascular Disease
N/A
Waitlist Available
Led By Charles K Ozaki, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients planned for non-emergency lower extremity vein bypass surgery
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effects of a short-term pre-operative diet of protein and calories to a normal diet on patients undergoing vascular surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects aren't listed but may include typical dietary change reactions such as fatigue, digestive discomfort or changes in blood sugar levels due to the pre-operative Protein-Calorie Restriction (PCR) diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for non-emergency surgery on the veins in my leg.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change over time from baseline values to values before surgery and day 1 after surgery in the comparison of H2S and standard biological markers of stress in blood
Compliance with outpatient Protein-Calorie Restriction measured via biologic assays for plasma free amino acids
Compliance with outpatient Protein-Calorie Restriction measured via biologic assays for pre-albumin
+3 moreSecondary outcome measures
Comparison of surgical and medical complications
One-year survival
Renal dysfunction, stroke, myocardial infarction, patency of the vein graft (primary, primary assisted, secondary), survival.
+1 moreOther outcome measures
Gut microbiome Analysis
Microbiome-derived circulating metabolites
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Protein-calorie restrictionExperimental Treatment1 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: ControlActive Control1 Intervention
Ad libitum diet for four days immediately before surgery
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,651 Total Patients Enrolled
Charles K Ozaki, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
19 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.Doctors think you will live for at least one more year.Your albumin level is lower than 3.0.I am younger than 18 years old.I am scheduled for non-emergency surgery on the veins in my leg.I had emergency surgery on the blood vessels in my leg.I am 18 years old or older.Doctors think you may live for less than one year.You are allergic to any of the ingredients in Scandi-Shake.
Research Study Groups:
This trial has the following groups:- Group 1: Protein-calorie restriction
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there current vacancies for individuals to partake in this investigation?
"According to clinicaltrials.gov, this specific medical trial is no longer recruiting patients; the study was initially posted on March 1st 2024 and last modified on July 7th 2022. Despite that, 358 other trials are presently enrolling participants."
Answered by AI
What are the primary aims of this experiment?
"This clinical trial is programmed to run for roughly one month and it's primary objective is to observe the change in H2S levels combined with traditional biological markers of stress from baseline before surgery, to post-surgery values. Secondary goals include monitoring wound complications such as superficial or deep surgical site infections (SSI) or dehiscence, comparison of medical versus surgical contingencies, and tracking renal dysfunction, stroke incidents, myocardial infarction rates, graft patency efficacy and patient survival. Mathematically integrated data will form the basis for a final integrative model."
Answered by AI
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