Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
NCT ID: NCT01885728
Last Updated: 2016-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2013-07-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arginine rich nutritional supplement
237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery.
An arginine rich nutritional supplement
Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.
No nutritional supplement
No specific nutritional requirements have to be met in this group.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Martin Angst
OTHER
Responsible Party
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Martin Angst
Professor of Anesthesia
Principal Investigators
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Martin S Angst, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University SOM
Locations
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Stanford University Hospital
Stanford, California, United States
Countries
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Other Identifiers
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27485
Identifier Type: -
Identifier Source: org_study_id