Protein-calorie restriction for Vascular Diseases
Phase-Based Progress Estimates
Effectiveness
Safety
Brigham and Women's Hospital, Boston, MA
Vascular Diseases+1 More
Scandi-Shake - DietarySupplementEligibility
18+
All Sexes
What conditions do you have?
Select
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
Effectiveness Progress
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
Safety Progress
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: DietarySupplementControlNoIntervention 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
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 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.
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