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

November 4, 2016 updated by: Martin Angst

A Randomized, Controlled Study Evaluating the Immune-Modulatory Effects of Perioperative Administration of Arginine Rich Nutritional Supplements With Mass Cytometry in Patient Undergoing Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 84305
        • Stanford University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine)
  2. Patients pretreated (6 months) or currently on chemotherapy for cancer
  3. Patients on radiation therapy (within 6 months)
  4. Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake > 30 mg)
  5. Patients with metastatic disease
  6. Patients with active infectious disease (within 2 months)
  7. Patients with significant metabolic disease (e.g. diabetes type I)
  8. Patients with clinically significant organ dysfunction including renal and hepatic dysfunction
  9. Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty
  10. Patients with autoimmune disease (e.g. lupus)
  11. Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
  12. Undernourished patients as indicated by a weight loss >10% during the last 6 months
  13. Patients with galactosemia
  14. Patients who had undergone previous major abdominal surgery
  15. 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
  16. Pregnancy
  17. Other conditions compromising a participant's safety or the integrity of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arginine rich nutritional supplement
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
Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.
Other Names:
  • 'Impact' made by Nestle Corporation
No Intervention: No nutritional supplement
No specific nutritional requirements have to be met in this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
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.
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire.
Time Frame: Daily for duration of hospital stay, then every 3 days trough postoperative week 5.
Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs.
Daily for duration of hospital stay, then every 3 days trough postoperative week 5.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
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
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
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
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Capacity of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Martin Angst

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin S Angst, MD, Stanford University SOM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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