Protein-calorie restriction for Vascular Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Vascular Diseases+1 More
Scandi-Shake - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. After a pilot study exploring the safety and feasibility of the PCR diet conducted inpatient before carotid endarterectomy titled Short-Term Endogenous Hydrogen Sulfide Upregulation, and a follow-up study titled Dietary Restriction in Vascular Surgery, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures. This study will further elucidate not only the practicality of pre-operative short term dietary restriction, but also provide early data to inform biologic mechanisms and to inform future efficacy trails.

Eligible Conditions

  • Vascular Diseases
  • Surgery

Treatment Effectiveness

Study Objectives

6 Primary · 4 Secondary · Reporting Duration: 2 years

0-34 days
Gut microbiome Analysis
Microbiome-derived circulating metabolites
1 Month
Comparison of surgical and medical complications
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
Compliance with outpatient Protein-Calorie Restriction measured via biologic assays insulin-like growth factor
Compliance with outpatient Protein-Calorie Restriction measured via food diary
Wound Complication
1 Month, 1 year
Renal dysfunction, stroke, myocardial infarction, patency of the vein graft (primary, primary assisted, secondary), survival.
1 year
One-year survival
2 years
Major Adverse Limb Event
Day 1
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

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Protein-calorie restriction
1 of 2
Active Control
Experimental Treatment

226 Total Participants · 2 Treatment Groups

Primary Treatment: Protein-calorie restriction · No Placebo Group · N/A

Protein-calorie restriction
DietarySupplement
Experimental Group · 1 Intervention: Scandi-Shake · Intervention Types: DietarySupplement
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Trial Background

Prof. C. Keith Ozaki M.D., F.A.C.S., John A. Mannick Professor of Surgery
Principal Investigator
Brigham and Women's Hospital
Closest Location: Brigham and Women's Hospital · Boston, MA
Photo of Boston  1Photo of Boston  2Photo of Boston  3
2008First Recorded Clinical Trial
9 TrialsResearching Vascular Diseases
1041 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to provide informed consent.
You have albumin ≥3.0 and a negative pregnancy test (if relevant).
You are at least 18 years old.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References