Dietary Restriction in Vascular Surgery

NCT04013412 | Completed

• 1 other identifier: 2018P002133
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. This study is a step in the long-term primary scientific objective to test the hypothesis that brief up regulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.

Conditions

Vascular Diseases; Surgery

Outcome Measures

Primary Outcomes (2)

• Outpatient compliance with protein calorie restriction

  Patient compliance with the PCR diet will be assessed by food record analysis.

  1 Month

• Comparison of H2S and related biological markers of stress

  Biologic markers include: adipose phenotyping (quantification of adipokines, adipose derived hormones), leukocyte phenotyping and quantification via flow cytometry, and serum assays of IL-1beta, IL-6, IL-8, HGF, leptin, MCP-1, PAI-1, resistin, NGF, TNF, adiponectin, hydrogen sulfide (including production capacity) assays, insulin, lipid panels, FGF 21, pre-albumin, epinephrine, norepinephrine, dopamine, CBC with differential, basic metabolic panel including calcium. H2S and biologic markers will be compared at baseline, immediately before surgery, and the day after surgery.

  1 Month

Study Arms (2)

Protein-Calorie Restriction

EXPERIMENTAL

Four day dietary intervention immediately before surgery of ScandiShake \[any of 4 flavors\] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level.

Dietary Supplement: Protein-Calorie Restriction

Control

NO INTERVENTION

Ad libitum diet for four days immediately before surgery

Interventions

Protein-Calorie Restriction DIETARY_SUPPLEMENT

Four day dietary intervention immediately before surgery of ScandiShake \[any of 4 flavors\] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level.

Protein-Calorie Restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients greater than 18 years old who present for one of the following elective procedures at Brigham and Women's Hospital
• Carotid artery endarterectomy
• Aortic/iliac aneurysm repair (open, and endovascular if groin cut down planned)
• Open lower extremity arterial procedures (bypasses, aneurysm repair, arterial and bypass graft reconstructions)
• Major amputation of the lower extremity (below knee and above knee amputations).
• Open hemodialysis access procedures

You may not qualify if:

• Patient intolerance or allergy to any of the ingredients in the PCR diet
• Active infection
• Pregnancy
• Malnutrition, based on abnormally low serum albumin (lower than 3 g/dL)
• Uncontrolled diabetes (HgbA1c greater than 12%)
• Substance dependency that could interfere with protocol adherence and assent as determined by the PI
• Active non-cutaneous cancer under treatment with chemotherapeutics or radiation
• Emergency surgery
• Active participation in any another interventional or randomized study
• Participation in the current study within the past 30 days

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Hine C, Kim HJ, Zhu Y, Harputlugil E, Longchamp A, Matos MS, Ramadoss P, Bauerle K, Brace L, Asara JM, Ozaki CK, Cheng SY, Singha S, Ahn KH, Kimmelman A, Fisher FM, Pissios P, Withers DJ, Selman C, Wang R, Yen K, Longo VD, Cohen P, Bartke A, Kopchick JJ, Miller R, Hollenberg AN, Mitchell JR. Hypothalamic-Pituitary Axis Regulates Hydrogen Sulfide Production. Cell Metab. 2017 Jun 6;25(6):1320-1333.e5. doi: 10.1016/j.cmet.2017.05.003.

  PMID: 28591635 BACKGROUND

• Longchamp A, Harputlugil E, Corpataux JM, Ozaki CK, Mitchell JR. Is Overnight Fasting before Surgery Too Much or Not Enough? How Basic Aging Research Can Guide Preoperative Nutritional Recommendations to Improve Surgical Outcomes: A Mini-Review. Gerontology. 2017;63(3):228-237. doi: 10.1159/000453109. Epub 2017 Jan 5.

  PMID: 28052287 BACKGROUND

• Longchamp A, Tao M, Bartelt A, Ding K, Lynch L, Hine C, Corpataux JM, Kristal BS, Mitchell JR, Ozaki CK. Surgical injury induces local and distant adipose tissue browning. Adipocyte. 2015 Nov 20;5(2):163-74. doi: 10.1080/21623945.2015.1111971. eCollection 2016 Apr-Jun.

  PMID: 27386152 BACKGROUND

• Robertson LT, Trevino-Villarreal JH, Mejia P, Grondin Y, Harputlugil E, Hine C, Vargas D, Zheng H, Ozaki CK, Kristal BS, Simpson SJ, Mitchell JR. Protein and Calorie Restriction Contribute Additively to Protection from Renal Ischemia Reperfusion Injury Partly via Leptin Reduction in Male Mice. J Nutr. 2015 Aug;145(8):1717-27. doi: 10.3945/jn.114.199380. Epub 2015 Jun 3.

  PMID: 26041674 BACKGROUND

• Hine C, Harputlugil E, Zhang Y, Ruckenstuhl C, Lee BC, Brace L, Longchamp A, Trevino-Villarreal JH, Mejia P, Ozaki CK, Wang R, Gladyshev VN, Madeo F, Mair WB, Mitchell JR. Endogenous hydrogen sulfide production is essential for dietary restriction benefits. Cell. 2015 Jan 15;160(1-2):132-44. doi: 10.1016/j.cell.2014.11.048. Epub 2014 Dec 23.

  PMID: 25542313 BACKGROUND

• Mauro CR, Tao M, Yu P, Trevino-Villerreal JH, Longchamp A, Kristal BS, Ozaki CK, Mitchell JR. Preoperative dietary restriction reduces intimal hyperplasia and protects from ischemia-reperfusion injury. J Vasc Surg. 2016 Feb;63(2):500-9.e1. doi: 10.1016/j.jvs.2014.07.004. Epub 2014 Aug 8.

  PMID: 25124359 BACKGROUND

• Nguyen B, Tao M, Yu P, Mauro C, Seidman MA, Wang YE, Mitchell J, Ozaki CK. Preoperative diet impacts the adipose tissue response to surgical trauma. Surgery. 2013 Apr;153(4):584-93. doi: 10.1016/j.surg.2012.11.001. Epub 2012 Dec 27.

  PMID: 23274098 BACKGROUND

• Mitchell JR, Beckman JA, Nguyen LL, Ozaki CK. Reducing elective vascular surgery perioperative risk with brief preoperative dietary restriction. Surgery. 2013 Apr;153(4):594-8. doi: 10.1016/j.surg.2012.09.007. Epub 2012 Dec 4.

  PMID: 23218877 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Charles K Ozaki, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John A. Mannick Professor of Surgery

Model Details: 3:2 randomization to short-term protein calorie restriction diet versus regular meals prior to elective major vascular surgery

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 9, 2019
• Study Start: December 31, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)