Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients

NCT01885728 | Completed

• 1 other identifier: 27485
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to characterize the immune-modulatory effects of arginine-rich nutritional supplements in patients undergoing surgery. Numerical and functional changes of all circulating immune cells will be assessed with mass cytometry.

Conditions

Immunity

Outcome Measures

Primary Outcomes (2)

• Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.

  The fraction of MDSCs will be quantified.

  Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.

• Functional status change of myeloid-derived suppressor cells (MDSC) from baseline.

  Intracellular phosphorylation events in MDSCs will be quantified.

  Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.

Secondary Outcomes (1)

• Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire.

  Daily for duration of hospital stay, then every 3 days trough postoperative week 5.

Other Outcomes (4)

• Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells

  Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.

• Functional status of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells

  Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.

• Functional potency of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells

  Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.

Study Arms (2)

Arginine rich nutritional supplement

ACTIVE COMPARATOR

237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery.

Dietary Supplement: An arginine rich nutritional supplement

No nutritional supplement

NO INTERVENTION

No specific nutritional requirements have to be met in this group.

Interventions

An arginine rich nutritional supplement DIETARY_SUPPLEMENT

Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.

Also known as: 'Impact' made by Nestle Corporation

Arginine rich nutritional supplement

Eligibility Criteria

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

You may qualify if:

• Colon surgery for cancer
• Patients ≥ 18 and ≤65 years of age
• Patients willing and able to sign an informed consent form and Health Insurance and Portability Act (HIPAA) authorization and to comply with study procedures

You may not qualify if:

• Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine)
• Patients pretreated (6 months) or currently on chemotherapy for cancer
• Patients on radiation therapy (within 6 months)
• Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake \> 30 mg)
• Patients with metastatic disease
• Patients with active infectious disease (within 2 months)
• Patients with significant metabolic disease (e.g. diabetes type I)
• Patients with clinically significant organ dysfunction including renal and hepatic dysfunction
• Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty
• Patients with autoimmune disease (e.g. lupus)
• Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
• Undernourished patients as indicated by a weight loss \>10% during the last 6 months
• Patients with galactosemia
• Patients who had undergone previous major abdominal surgery
• Participation in another clinical trial of an investigational drug or device within the last 30 days prior to the first day of study that, in the investigator's opinion, would create increased risk to the participant or compromise the integrity or either study

Sponsors & Collaborators

• Martin Angst: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 84305, United States

Location

Study Officials

• Martin S Angst, MD

  Stanford University SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 25, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

US (1)