Status:
COMPLETED
Short-Term Endogenous Hydrogen Sulfide Upregulation
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Carotid Stenosis
Caloric Restriction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research study will compare the impact of dietary restriction pre-operatively before carotid endarterectomy compared to the standard nutrition that a patient typically eats. The investigators wan...
Detailed Description
The primary, scientific long term objective is to study any correlation that brief upregulation of endogenous hydrogen sulfide (H2S) via pre-operative protein calorie restriction (PCR) in elective maj...
Eligibility Criteria
Inclusion
- consenting adults (men and women)
- clinical indication for carotid endarterectomy (CEA) as determined by attending vascular surgeon
- if symptomatic, patients must be able to safely have surgery timed for PCR intervention
Exclusion
- intolerance or allergy to any ingredients in the PCR diet (ScandiShake ingredients or almond milk/nuts)
- active infection
- pregnancy
- malnutrition determined by serum albumin lower than BWH reference value of 3.5 g/dL
- active drug dependency or alcoholism that could interfere with protocol adherence
- active non-cutaneous cancer under treatment with chemotherapeutic
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03303534
Start Date
September 14 2017
End Date
June 1 2018
Last Update
June 28 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115